Class 2 Device Recall CONSTELLATION ULTRAVIT 10K CONSTELLATION HYPERVIT 20K

• Date Initiated by Firm: September 15, 2025
• Date Posted: November 21, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0581-2026
• Recall Event ID: 97728
• 510(K)Number: K110951
• Product Classification: Photocoagulator and accessories - Product Code HQB
• Product: CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1
• Code Information: UDI-DI/REF: 5414660389996/C26992-01; 5414660396666/C23069-05; 5414660396697/C23125-04; 5414660400332/C17655-06; 5414660400356/C17731-06; 5414660401254/C27454-02; 5414660401285/C27450-02; 5414660401292/C27449-02; 5414660405221/C27453-03; 5414660409380/C27818-04; 5414660409700/C27864-01 5414660410225/C27876-01; 5414660413356/C28044-05; 5414660413691/C19139-07; 5414660417668/C25243-02; 5414660418221/C27440-02; 5414660418238/C27441-03, 5414660418245/C27442-02; 5414660418252/C27443-02; 5414660418269/C27444-02; 5414660418276/C27445-02; 5414660420620/C28328-02; 5414660421061/C21524-03; 5414660421078/C18093-04; 5414660421993/C27789-08; 5414660423874/C27007-03; 5414660427759/C19940-07; 5414660429029/C26049-02; 5414660434382/C29260-01; 5414660434412/C26740-08; 5414660434429/C26739-09; 5414660434443/C21175-07; 5414660434450/C28294-04; 5414660434542/C24151-06; 5414660434559/C29080-03; 5414660434580/C28885-03; 5414660434597/C28884-03; 5414660434603/C28883-05; 5414660434658/C27558-03; 5414660434665/C20382-07; 5414660434733/C29015-03; 5414660434870/C24900-04; 5414660434931/C27086-04; 5414660434948/C27091-05; 5414660435150/C28673-03; 5414660435167/C28738-03; 5414660435228/C29261-01/ 5414660435617/C26731-04; 5414660435648/C22375-13; 5414660435662/C26854-09; 5414660436171/C29271-01; 5414660436263/C29272-01; 5414660436539/C28996-04; 5414660436591/C25163-05; 5414660436607/C22118-04; 5414660436744/C23137-11; 5414660436768/C25162-05; 5414660436775/C26763-04; 5414660444206/C28786-01; 5414660446538/C28835-01; 5414660447726/C28795-02; 5414660448983/C28005-03; 5414660448990/C28024-04; 5414660450610/C28908-01; 5414660450948/C27548-02; 5414660450955/C27549-02; 5414660450962/C27550-02; 5414660453888/C28686-03; 5414660454977/C24333-05; 5414660456223/C28950-01; 5414660457237/C19081-10, C19081-10-01; 5414660457985/C26224-06; 5414660458975/C21162-07; 5414660459019/C24998-04; 5414660459439/C25768-03; 5414660461555/C19947-10; 5414660462576/C22297-04; 5414660462880/C28595-02; 5414660462903/C28596-02; 5414660462910/C28597-02; 5414660462934/C28977-01; 5414660463344/C22052-05; 5414660463399/C26609-05; 5414660463795/C27623-02; 5414660463801/C27624-02; 5414660463825/C27626-02; 5414660463832/C27627-02; 5414660464082/C22117-03; 5414660468615/C28999-01; 5414660469711/C28001-02 5414660469728/C28002-02; 5414660469827/C27999-08; 5414660470335/C27657-04-01; 5414660471752/C26040-04; 5414660471790/C28003-02; 5414660473756/C27328-04; 5414660474968/C28765-02; 5414660475941/C24814-05; 5414660476436/C25201-09; 5414660476511/C28707-03; 5414660476986/C28291-07; 5414660477532/C24780-08; 5414660478423/C28854-03; 5414660479093/C29031-01; 5414660481874/C29033-01; 5414660481911/C29029-01; 5414660481928/C29030-01; 5414660481935/C29034-01; 5414660484073/C20919-08; 5414660484264/C20349-06; 5414660484851/C22527-06; 5414660484868/C22554-08; 5414660485605/C23537-05; 5414660485636/C23536-04; 5414660485988/C24281-03; 5414660486442/C25025-04; 5414660487760/C26041-06; 5414660488101/C27320-02; 5414660488767/C27693-02; 5414660488774/C27694-02; 5414660488804/C27658-02; 5414660489818/C19154-10; 5414660490128/C25225-09; 5414660490395/C25959-04; 5414660491682/C25957-03; 5414660491699/C25958-03; 5414660494720/C29110-01; 5414660496755/C26228-04; 5414660497172/C23619-09; 5414660497219/C26097-04; 5414660497820/C14928-07; 5414660497844/C23093-07; 5414660497868/C29014-03; 5414660498384/C26075-04; 5414660499725/C26610-06; 5414660499787/C27764-03; 5414660501381/C27228-03; 5414660501398/C27655-05; 5414660501459/C28256-07; 5414660502661/C28764-02; 5414660503286/C20781-07; 5414660503620/C27756-05; 5414660503668/C27763-02; 5414660504641/C24680-06; 5414660504658/C24681-07; 5414660505006/C29116-02; 5414660505013/C29117-02; 5414660505112/C28952-05; 5414660505129/C28953-05; 5414660505266/C23620-08; 5414660505655/C20782-07; 5414660505716/C28004-02; 5414660505853/C24442-08; 5414660506423/C27998-03; 5414660506454/C25919-10; 5414660506508/C24133-14; 5414660506522/C28894-02; 5414660506560/C23790-13; 5414660506836/C20681-11; 5414660506942/C20682-10; 5414660506959/C21121-11; 5414660507048/C22061-12; 5414660507079/C22065-07; 5414660507215/C25858-10; 5414660507697/C28370-10; 5414660507703/C28373-04; 5414660507895/C25200-10; 5414660508335/C26614-04; 5414660508342/C26615-04; 5414660508359/C26617-04; 5414660508366/C26619-04; 5414660508427/C24959-07; 5414660508465/C29182-01; 5414660508489/C29180-01; 5414660509554/C28382-06; 5414660509851/C29200-01; 5414660509936/C25139-10; 5414660509967/C25138-11; 5414660510598/C25050-06; 5414660510604/C25435-09; 5414660510659/C28094-04; 5414660510703/C28984-02; 5414660510796/C25047-05; 5414660510970/C27928-06; 5414660510987/C27961-09; 5414660511083/C28112-04; 5414660511106/C28100-04; 5414660511151/C26906-04; 5414660511168/C26907-04; 5414660511205/C24570-04; 5414660511335/C27396-04; 5414660511359/C25531-11; 5414660511489/C24696-05; 5414660511618/C27551-03; 5414660511687/C26019-09; 5414660511731/C26489-03; 5414660511748/C26490-04; 5414660511823/C26769-06; 5414660511908/C27552-04; 5414660512059/C28837-04; 5414660512158/C28179-05; 5414660512172/C29139-02; 5414660512219/C28233-04; 5414660512226/C28975-02; 5414660512240/C27606-03; 5414660512257/C27607-03; 5414660512349/C28652-03; 5414660512370/C24985-06; 5414660512448/C27395-04; 5414660512530/C24978-05; 5414660512547/C25295-08; 5414660512585/C25296-05; 5414660512592/C25297-06; 5414660512615/C27610-04; 5414660512622/C27611-03; 5414660512639/C28689-04; 5414660512653/C28690-03; 5414660512660/C19291-10; 5414660512677/C27697-02; 5414660512684/C27702-04; 5414660512752/C27962-08; 5414660512769/C28077-03; 5414660512790/C28265-07; 5414660512813/C24602-08; 5414660512837/C17778-13; 5414660512851/C26239-06; 5414660512868/C28282-05; 5414660512912/C27993-04; 5414660512950/C28074-05; 5414660513155/C22383-05; 5414660513179/C27528-02; 5414660513216/C29134-02; 5414660513261/C27527-02; 5414660513322/C24935-15; 5414660513360/C22382-06; 5414660513575/C20591-12; 5414660513766/C28680-03; 5414660513810/C24933-11; 5414660513827/C24934-12; 5414660513889/C20592-11; 5414660513902/C27188-03; 5414660513964/C17271-07; 5414660514077/C28099-04; 5414660514107/C28178-05; 5414660514213/C24153-05; 5414660514572/C29078-03; 5414660514589/C29079-03; 5414660514749/C28954-06; 5414660514831/C29210-01; 5414660514992/C28262-03; 5414660515029/C20678-09; 5414660515098/C17593-14; 5414660515166/C28086-04; 5414660515456/C24258-08; 5414660515609/C27813-09; 5414660515685/C28283-05; 5414660515760/C27267-06; 5414660515814/C27753-03; 5414660515951/C28231-03; 5414660515975/C25436-03; 5414660515982/C27019-03; 5414660516019/C27020-04; 5414660516026/C27733-06; 5414660516118/C25909-05; 5414660516149/C28529-04, C28482-08-01; 5414660516170/C28985-02; 5414660516279/C29124-02; 5414660516286/C29130-02; 5414660516309/C29129-02; 5414660516330/C28096-03; 5414660516347/C27022-04; 5414660516545/C25994-09; 5414660516583/C27021-03; 5414660516590/C27023-03; 5414660516606/C27024-05; 5414660516644/C27908-03; 5414660516651/C28234-04; 5414660516668/C28335-01; 5414660516675/C28337-02; 5414660516903/C28528-03; 5414660516941/C28969-03; 5414660516965/C29086-03; 5414660516996/C29125-02; 5414660517146/C25323-04; 5414660517153/C29020-03; 5414660517221/C27793-02; 5414660517238/C29215-01; 5414660517368/C28620-05-01, C28670-03; 5414660517443/C26416-04; 5414660517450/C27303-04; 5414660517504/C26186-07; 5414660517511/C26231-07; 5414660517528/C26232-08; 5414660517689/C26189-07; 5414660517696/C26234-07; 5414660517726/C25908-04; 5414660517740/C28978-02; 5414660517757/C29216-01; 5414660518143/C22879-09; 5414660518150/C29217-02; 5414660518181/C24507-10; 5414660518204/C24501-11; 5414660518280/C24136-08; 5414660518303/C26895-06; 5414660518471/C28624-05; 5414660518679/C26229-03; 5414660518884/C22186-06; 5414660518907/C25088-05; 5414660519157/C27726-04; 5414660519164/C27732-06; 5414660519195/C29224-01; 5414660519744/C28891-05; 5414660519782/C29226-01; 5414660519799/C29227-01; 5414660519973/C29138-03; 5414660520221/C22778-04; 5414660520245/C22777-05; 5414660520405/C24966-08; 5414660520412/C25132-07; 5414660520443/C25227-07; 5414660520535/C29006-03; 5414660520566/C27496-04; 5414660520603/C22544-09; 5414660520634/C22541-10; 5414660520641/C22543-09; 5414660520672/C25663-07; 5414660520764/C22540-09; 5414660520795/C29239-01; 5414660520825/C29241-01; 5414660521051/C29111-02; 5414660521167/C29037-05; 5414660521273/C27769-03; 5414660521310/C27787-07; 5414660521341/C28115-04; 5414660521358/C28097-03; 5414660521389/C29238-01; 5414660521792/C22385-10; 5414660521921/C28993-03; 5414660521938/C28997-03; 5414660521945/C23233-06; 5414660521952/C26667-05; 5414660522034/C22087-07, C22087-07-01; 5414660522065/C21792-08; 5414660522294/C29016-05; 5414660522324/C22086-07, C22086-07-01; 5414660522393/C23735-09; 5414660522409/C23739-09; 5414660522515/C25386-05; 5414660522751/C28470-03; 5414660522898/C25372-06; 5414660522904/C25373-06; 5414660522911/C25374-06; 5414660522942/C16966-14, C16966-14-01, 5414660522959/C16967-13, C16967-13-01; 5414660523147/C25322-06 5414660523338/C28462-03, C28429-03; 5414660523413/C21304-11, C21304-11-01; 5414660523635/C29305-01; 5414660523666/C25031-06; 5414660523673/C25065-04; 5414660523703/C27657-04; 5414660523819/C28026-02; 5414660523833/C28042-05; 5414660523925/C28034-05; 5414660524007/C25064-05, C25064-05-01; 5414660524021/C20486-16; 5414660524038/C20492-15; 5414660524069/C29307-01; 5414660524151/C29201-02; 5414660524175/C29200-02; 5414660524243/C20578-08, C20578-08-01; 5414660524274/C21958-08, C21958-08-01; 5414660524342/C24896-08; 5414660524359/C21873-11; 5414660524366/C21876-11; 5414660524373/C22248-06; 5414660524380/C28829-03; 5414660524397/C28830-03; 5414660524403/C17970-14; 5414660524427/C24895-08; 5414660524489/C28339-02; 5414660524496/C28356-03; 5414660524700/C29221-02; 5414660524762/C25607-05; 5414660524786/C29314-01; 5414660524793/C28769-03; 5414660524809/C28766-03; 5414660524830/C25367-06; 5414660524908/C28251-05; 5414660524953/C25366-06; 5414660525134/C27319-02; 5414660525240/C29322-01; 5414660525257/C29323-01; 5414660525264/C29324-01; 5414660525400/C28254-07; 5414660525424/C26042-05; 5414660525479/C25321-08; 5414660525639/C24090-07; 5414660525653/C24088-12; 5414660525677/C24089-12; 5414660525820/C28250-05; 5414660525837/C28823-07; 5414660525967/C28236-03; 5414660526285/C26376-05; 5414660526315/C27278-06; 5414660526360/C26375-05; 5414660526384/C19283-09; 5414660526452/C28803-06; 5414660526490/C28801-06; 5414660526506/C28802-06; 5414660526537/C28800-06; 5414660526575/C29341-01; 5414660526612/C28047-01; 5414660526650/C26379-05;; 5414660526797/C24127-09, C24127-09-01; 5414660526841/C22954-10; 5414660526933/C22951-10, C22951-10-01; 5414660527015/C27710-08; 5414660527022/C27711-04; 5414660527039/C27712-03; 5414660527053/C28866-02; 5414660527244/C28482-07; 5414660527343/C23842-11, C23842-11-01; 5414660527350/C19886-13; 5414660527367/C22172-15-01, C22171-16-01; 5414660527398/C22172-15, C22171-16, C22145-07; 5414660527473/C17890-12; 5414660527503/C23816-05; 5414660527510/C25568-03; 5414660527541/C21071-11, C21071-11-01; 5414660527572/C24244-09; 5414660527589/C24245-09; 5414660527602/C26524-06; 5414660527732/C29360-01; 5414660527763/C29010-04; 5414660527770/C29361-01; 5414660527831/C29351-02; 5414660527848/C29352-02; 5414660527855/C29353-03; 5414660527879/C29354-03; 5414660527909/C29355-02; 5414660527930/C28771-03; 5414660527961/C28770-03; 5414660528203/C27655-06; 5414660528210/C29373-01; 5414660528258/C29362-01; 5414660528357/C26770-07; 5414660528364/C27025-09; 5414660528395/C28624-06; 5414660528487/C25239-06; 5414660528500/C20744-14; 5414660528562/C29379-01; 5414660528814/C29386-01; 5414660528852/C29389-01; 5414660528876/C29375-03; 5414660528944/C29387-01; 5414660529019/C24896-10; 5414660529064/C29394-01; 5414660529095/C29305-02; 5414660529194/C29406-01; 5414660529293/C24343-05; 5414660529316/C24342-05; 5414660529729/C22186-07; 5414660529781/C22187-07; 5414660529859/C24485-11; 5414660529927/C28619-07; 5414660530008/C29415-01; 5414660530022/C29417-01; 5414660530077/C29391-01; 5414660530084/C29396-01; 5414660530091/C29302-03; 5414660530152/C28852-04; 5414660530350/C28856-05; 5414660530411/C27086-05; 5414660530428/C27091-06; 5414660530473/C28855-05; 5414660530541/C27007-04; 5414660530589/C24127-10, C24127-10-01; 5414660530596/C24483-08; 5414660530633/C16833-13; 5414660530657/C21630-16; 5414660530671/C22954-11, C22954-11-01; 5414660530688/C24090-08; 5414660530695/C24794-09; 5414660530701/C25472-14; 5414660530725/C22951-11, C22951-11-01; 5414660530732/C24087-11; 5414660530763/C25683-11; 5414660530770/C25684-11; 5414660530787/C26763-07; 5414660530794/C28712-03; 5414660530817/C20014-13; 5414660530824/C23790-14; 5414660530831/C28482-08, C28482-07-01; 5414660530992/C24089-13; 5414660531104/C28374-04; 5414660531128/C29223-03; 5414660531135/C29239-02; 5414660531142/C29241-02; 5414660531166/C29224-03; 5414660531173/C29226-03; 5414660531197/C28375-06; 5414660531210/C23818-09; 5414660531227/C24088-13; 5414660531272/C29227-03; 5414660531388/C26172-04; 5414660531630/C20486-17; 5414660531722/C29029-02; 5414660531777/C26156-06; 5414660531784/C27088-04; 5414660532071/C24450-07; 5414660532132/C22029-06; 5414660532248/C20349-07; 5414660532361/C29032-02; 5414660532385/C19676-16; 5414660532392/C24604-11; 5414660532415/C28462-04; 5414660532422/C28470-04; 5414660532446/C29033-02; 5414660532484/C21066-09; 5414660532514/C27090-04; 5414660532552/C29031-02; 5414660532606/C24780-09; 5414660532637/C27084-05; 5414660532743/C28854-04; 5414660532750/C29030-02; 5414660532941/Q29257-01; 5414660532958/Q29258-01; 5414660532972/Q29260-01; 5414660532989/Q29261-01; 5414660533009/C26625-07; 5414660533030/C28074-04; 5414660533344/C16966-15, C16966-15-01, C16966-16, C16966-16-01; 5414660533511/C22248-07; 5414660533528/C16967-14, C16967-14-01; 5414660533603/C24934-13; 5414660533610/C24936-09; 5414660533658/C24935-16; 5414660533689/C22541-11; 5414660533696/C22543-10; 5414660534082/C25590-08; 5414660534143/C20492-16; 5414660534167/C23619-10; 5414660534174/C23620-09; 5414660534181/C24725-13; 5414660534242/C26097-05; 5414660534297/C20490-24; 5414660534303/C24387-11; 5414660534655/C25662-09; 5414660534686/C29277-02; 5414660534792/C28991-05; 5414660534860/C23137-12; 5414660534877/C25132-09; 5414660534907/C29426-01; 5414660534914/C22540-11; 5414660534921/C25227-09; 5414660534938/C26815-08; 5414660534945/C29037-07; 5414660535065/C24966-10; 5414660535089/C24671-05; 5414660535102/C20678-10; 5414660535119/C22203-06; 5414660535126/C28294-02; 5414660535133/C24133-16; 5414660535140/C25087-06; 5414660535157/C26175-06; 5414660535171/C28079-04; 5414660535188/C25226-10; 5414660535218/C28952-06; 5414660535225/C26176-07; 5414660535249/C28954-07; 5414660535423/C19827-16; 5414660535454/C28953-06; 5414660535607/C19619-11; 5414660535713/C26489-04; 5414660535737/C27911-06; 5414660535775/C22061-13; 5414660535874/C26739-10; 5414660535904/C27610-05; 5414660535911/C28517-06; 5414660535928/C29428-01; 5414660535942/C19829-18; 5414660535959/C22201-07; 5414660535966/C27818-03; 5414660535997/C19081-11, C19081-11-01; 5414660536024/C23736-13; 5414660536031/C25184-08; 5414660536048/C27496-05; 5414660536055/C27396-05; 5414660536079/C25486-08; 5414660536086/C27397-05; 5414660536130/C28304-06; 5414660536154/C25088-08; 5414660536208/C26490-05; 5414660536222/C27395-05; 5414660536352/C19976-16; 5414660536543/C19899-16; 5414660536567/C28823-08; 5414660536574/C29006-06; 5414660536635/C24900-05, C24900-05-01; 5414660536666/C29047-04; 5414660536765/C25910-06; 5414660536796/C19898-19; 5414660536802/C22323-08; 5414660536826/C20006-18; 5414660536840/C25607-06; 5414660536857/C27398-05; 5414660536864/C27961-08; 5414660537410/C21731-04; 5414660537427/C21304-12, C21304-12-01; 5414660537434/C29138-04; 5414660537458/C25064-06, C25064-06-01; 5414660537489/C25766-06; 5414660537564/C28999-02; 5414660537595/C29139-03; 5414660537816/C24933-13; 5414660537830/C25435-10; 5414660537847/C29438-01; 5414660537885/C25323-05; 5414660537892/C29433-01; 5414660538240/C26224-07; 5414660538271/C24895-09; 5414660538288/C24896-11; 5414660538295/C25185-08; 5414660538363/C28764-03; 5414660538516/C29323-02; 5414660538554/C21113-13; 5414660538561/C21813-14; 5414660538592/C29322-02; 5414660538639/C23806-08; 5414660538707/C22544-12; 5414660538738/C19778-27; 5414660538820/C23050-18; 5414660538882/C29420-02; 5414660538936/C29246-03; 5414660538974/C29217-03; 5414660538998/C29089-06; 5414660539063/C29335-02; 5414660539070/C29439-01; 5414660539100/C29434-01; 5414660539209/C28891-06; 5414660539230/C24374-07; 5414660539308/C29240-03; 5414660539339/C25858-11; 5414660539360/C20682-11; 5414660539377/C21121-12; 5414660539544/C20681-12; 5414660539582/C28620-05; 5414660539643/C28671-05; 5414660539681/C25531-12; 5414660539711/C29445-01; 5414660539803/C20843-08; 5414660539810/C23723-15; 5414660539858/C27723-04; 5414660539865/C27724-04; 5414660539902/C26019-10; 5414660539919/C26474-05; 5414660539926/C28031-05; 5414660539933/C29450-01; 5414660540007/C27713-03; 5414660540076/C22498-13; 5414660540120/C25279-10; 5414660540175/C27810-11; 5414660540182/C22590-10; 5414660540199/C27794-03; 5414660540229/C27811-13; 5414660540304/C24603-11; 5414660540335/C24604-12; 5414660540397/C28357-03; 5414660540427/C26855-10; 5414660540465/C24602-09; 5414660540496/C22367-20; 5414660540540/C24812-09; 5414660540601/C21410-07; 5414660540625/C29464-01; 5414660540656/C26851-04; 5414660540687/C29469-01; 5414660540748/C29468-01; 5414660540755/C21873-12; 5414660540762/C25475-14; 5414660540786/C26521-05; 5414660540793/C26854-10; 5414660540809/C27896-01; 5414660540823/C21876-12; 5414660540830/C24962-08; 5414660541004/C25661-04; 5414660541028/C21111-14; 5414660541141/C25663-10; 5414660541158/C22544-13; 5414660541172/C15050-21; 5414660541240/C25662-10; 5414660541257/C22540-12; 5414660541295/C28602-07; 5414660541516/C20017-09; 5414660541523/C20018-10; 5414660541608/C20349-08; 5414660541622/C24483-09; 5414660541639/C24570-06; 5414660541707/C29483-01; 5414660541721/C29480-01; 5414660541738/C29481-01; 5414660541813/C28326-02; 5414660541820/C28327-02; 5414660541844/C29489-01; 5414660541851/C29490-01; 5414660541868/C28320-04; 5414660541882/C24387-12; 5414660541912/C20490-25; 5414660541950/C22375-14; 5414660542094/C29492-01; 5414660542124/C29493-01; 5414660542209/C20006-19; 5414660542223/C26474-06; 5414660542292/C25994-10; 5414660542308/C27787-06; 5414660542322/C24442-09; 5414660542353/C28265-06; 5414660542377/C22432-10; 5414660542483/C27789-07; 5414660542506/C21650-10; 5414660542698/C28253-04; 5414660542704/C29497-01; 5414660542711/C29498-01; 5414660542735/C19988-23; 5414660542759/C19976-17; 5414660542773/C28256-06; 5414660542841/C23667-17; 5414660542858/C25203-11; 5414660542865/C25206-11; 5414660542940/C28708-04; 5414660542971/C29500-01; 5414660542988/C25366-07; 5414660543008/C17593-15; 5414660543022/C25367-07; 5414660543053/C29498-02; 5414660543084/C26282-05; 5414660543145/C27995-03; 5414660543213/C28370-09; 5414660543220/C24075-09; 5414660543237/C28993-04; 5414660543251/C24255-10; 5414660543299/C22871-11; 5414660543305/C29497-02; 5414660543312/C11112-13; 5414660543336/C21555-06; 5414660543435/C29433-02; 5414660543497/C26172-05; 5414660543602/C25132-10; 5414660543619/C27993-03; 5414660543756/C28250-04; 5414660543787/C28251-04; 5414660543817/C27441-04; 5414660543824/C28819-04; 5414660543855/C29520-01; 5414660543879/C25910-07; 5414660543916/C24002-06; 5414660543985/C22172-16; 5414660544005/C26907-05; 5414660544012/C27444-03; 5414660544036/C27440-03; 5414660544043/C27443-03; 5414660544067/C25571-04; 5414660544074/C25574-04; 5414660544241/C24374-08; 5414660544272/C28403-05; 5414660544333/C23378-08; 5414660544371/C29523-01; 5414660544395/C29524-01; 5414660544401/C23620-10; 5414660544463/C25322-07; 5414660544470/C25321-09; 5414660544487/C26623-09; 5414660544500/C26097-06; 5414660544524/C23619-11; 5414660544531/C26621-09; 5414660544593/C29526-01; 5414660544654/C25766-07; 5414660544722/C28024-02; 5414660544777/C29528-01; 5414660544876/C29530-01; 5414660544883/C29529-01; 5414660544906/C26341-06; 5414660544944/C27457-04; 5414660545002/C19676-17; 5414660545156/C29533-01; 5414660545279/C23736-14; 5414660545491/C29550-01; 5414660545583/C29554-01; 5414660545613/C29545-01; 5414660545620/C29548-01; 5414660545644/C29549-01; 5414660545675/C29552-01; 5414660545682/C29541-01; 5414660545712/C29547-01; 5414660545736/C26783-10; 5414660545743/C26784-07; 5414660545798/C21650-11; 5414660545828/C29551-01; 5414660545835/C22383-06; 5414660545910/C28428-03; 5414660545996/C29557-02; 5414660546016/C29227-04; 5414660546023/C25184-09; 5414660546054/C29555-01; 5414660546078/C26521-06; 5414660546085/C29562-01; 5414660546092/C24814-06; 5414660546115/C27396-06; 5414660546122/C25200-11; 5414660546153/C27397-06; 5414660546177/C29565-01; 5414660546214/C23667-18; 5414660546221/C28462-05; 5414660546269/C28470-05; 5414660546344/C29572-01; 5414660546368/C29570-01; 5414660546375/C29569-01; 5414660546412/C24794-10; 5414660546436/C16833-14; 5414660546498/C27455-04; 5414660546535/C20578-09, C20578-09-01; 5414660546542/C23502-08; 5414660546566/C23233-07; 5414660546580/C29581-01; 5414660546641/C21958-09, C21958-09-01; 5414660546658/C23503-08; 5414660546665/C29578-01; 5414660546696/C17271-08; 5414660546740/C24333-06; 5414660546771/C29584-01; 5414660546863/C22540-13; 5414660546870/C22544-14; 5414660546887/C25662-11; 5414660546894/C25663-11; 5414660546962/C22543-11; 5414660546979/C29590-01; 5414660546993/C29589-01; 5414660547037/C29588-01; 5414660547051/C22541-12; 5414660547211/C22879-10; 5414660547273/C29596-01; 5414660547310/C22172-16-01, C22184-16; 5414660547327/C22185-14; 5414660547341/C27911-05; 5414660547365/C24450-08; 5414660547495/C29557-03; 5414660547532/C26623-10; 5414660547556/C28294-03; 5414660547587/C20492-17; 5414660547600/C26621-10; 5414660547655/C25766-08; 5414660547662/C20490-26; 5414660547686/C22203-07; 5414660547754/C20486-18; 5414660547785/C22201-08; 5414660547822/C29606-01; 5414660547945/C28376-07; 5414660548058/C16562-15; 5414660548072/C27810-10; 5414660548089/C26156-07; 5414660548096/C27811-12; 5414660548119/C29610-01; 5414660548140/C24780-10; 5414660548157/C27813-08; 5414660548225/C29613-01; 5414660548362/C29614-01; 5414660548447/C26740-09; 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H5301ALCON1CPAK11/AS12852-16; H5301ALCON1CPAK12/18269-02; H5301ALCON1CPAK13/AS18269-02; H5301ALCON1CPAK14/12641-13; H5301ALCON1CPAK15/12641-14; H5301ALCON1CPAK16/AS12641-13; H5301ALCON1CPAK17/AS12641-14; H5301ALCON1CPAK18/18271-02; H5301ALCON1CPAK19/AS18271-02; H5301ALCON1CPAK20/17607-05; H5301ALCON1CPAK21/AS17607-05; H5301ALCON1CPAK22/20122-01; H5301ALCON1CPAK23/AS20122-01; H5301ALCON1CPAK24/17609-04; H5301ALCON1CPAK25/17609-05; H5301ALCON1CPAK26/17609-06; H5301ALCON1CPAK27/AS17609-04; H5301ALCON1CPAK28/AS17609-05; H5301ALCON1CPAK29/AS17609-06; H5301ALCON1CPAK30/18684-05; H5301ALCON1CPAK31/AS18684-05; H5301ALCON1CPAK32/18454-07; H5301ALCON1CPAK33/AS18454-07; H5301ALCON1CPAK34/18453-05; H5301ALCON1CPAK35/18453-06; H5301ALCON1CPAK36/AS18453-05; H5301ALCON1CPAK37/17368-04; H5301ALCON1CPAK38/AS17368-04; H5301ALCON1CPAK39/17369-04; H5301ALCON1CPAK40/AS17369-04; H5301ALCON1CPAK41/19747-01; H5301ALCON1CPAK42/AS19747-01; H5301ALCON1CPAK43/16873-11; H5301ALCON1CPAK44/AS16873-11; H5301ALCON1CPAK45/18833-04; H5301ALCON1CPAK46/AS18833-04; H5301ALCON1CPAK47/16873-09; H5301ALCON1CPAK48/AS16873-09; H5301ALCON1CPAK49/18826-03; H5301ALCON1CPAK50/AS18826-03; H5301ALCON1CPAK51/16871-10; H5301ALCON1CPAK52/16871-11; H5301ALCON1CPAK53/AS16871-10; H5301ALCON1CPAK54/AS16871-11; Customer evaluation sample - UDI N/A/QNS29389-01, QNS29388-01, QNS29239-01, QNS29385-01, QNS29407-01, QNS29406-01, QNS29365-01, QNS29364-01, QNS29374-01, QNS29373-01, QNS29337-01, QNS29338-01, QNS29339-01, QNS29333-01, QNS29353-01, QNS29352-01, QNS29348-01
• Recalling Firm/ Manufacturer: Alcon Research LLC; 6201 South Fwy; Fort Worth TX 76134-2099
• For Additional Information Contact: Kristen Kellerhals; 817-615-5472
• Manufacturer Reason for Recall: XXX
• FDA Determined Cause: Component change control
• Action: On 9/15/2025, correction notices were mailed to customers who were informed of the following: Suitable alternative probes are available. Please stop using affected UNITY ULTRAVIT 10K 25+ probes and contact your Alcon Sales Representative to arrange for replacement of your existing stock. No direct substitution is available for the 23 gauge size of UNITY ULTRAVIT 10K probes. To prevent a probe shortage and the resulting risk of cancelling emergency and time-sensitive posterior segment surgeries, Firm will continue to ship probes until non-affected probe inventory is available. Firm advises customers to take the following precautions with affected UNITY ULTRAVIT 10K 23G probes until non-affected probe inventory is available: 1) Strictly adhere to the Instructions for Use (IFU) regarding limitations, including maximum use time and single use only. 2) Reduce the actuation rate to no more than 5000 actuations per minute. 3) Adjust other related console settings as needed to accommodate the reduced cutting/actuation rate. 4) If a reduction of cutting capability or failure to actuate is observed during the surgical procedure, stop immediately. Take all necessary surgical precautions to remove the probe and replace it with an unused probe. Post this notification letter near where affected products are stored to make facility personnel aware of this Medical Device Correction and associated firm corrective action. Forward this notification to all departments within your organization who may be in possession of this affected product; and any other organization to which this product may have been transferred. Complete and return the response form via email to Market.Actions@Alcon.com Firm will notify customers regarding replacement inventory as soon as adequate inventory of new, non-affected probes is available. Adverse events can be reported to firm at: https://notifeye.alcon.com or by phone (1-800-757-9780, Option 5). Questions can be directed to firm customer servic
• Quantity in Commerce: 28323
• Distribution: Worldwide - US Nationwide distribution including in the states of PA, MN, CA, FL, LA, CO, KS, IL, AK, OH, NY, NM, DE, TX, GA, NJ, MI, SC, AR, IN, OR, VA, WI, AZ, TN, KY, AL, MA, WA, NE, MT, SD, CT, NC, MO, UT, WY, DC, NH, MD, ID, RI, ND, HI, ME, IA, MS, NV, OK, WV, VT and the countries of GB, CA, IE, CH, JP, AT, CZ, GR, HU, PL, TR, ZA, MU, ZM, SA, IL, KW, BD, UZ, LB, LV, AZ, MN, IR, MK, VN, MT, AE, ID, CY, MD, RS, QA, LK, DZ, EG, TN, BG, OM, HR, KH, IT, NL, LU, BE, JO, BH, ES, PT, FI, SE, DK, IS, RO, RU, UA, DE, FR, MQ, AU, NZ, HK, MO, SG, PH, PF, GF, GP, NC, RE, KR, IN, TH, TW, MY, BN, CN, IQ, SI, MA, CL, EC, MX, PE, PK, AR, BR, CO, UY, JM, BS, DO, TT, GT, CR, BB, AW, SK, KZ, BY, AM, SV, SR, KG, UG, PA, NI, PY, HN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HQB