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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Laboratories, Inc.

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 Class 2 Device Recall Alcon Laboratories, Inc.see related information
Date Initiated by FirmApril 28, 2025
Date PostedJuly 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2108-2025
Recall Event ID 96832
510(K)NumberK141065 
Product Classification Vitrectomy, instrument cutter - Product Code MLZ
ProductBrand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A
Code Information Lot Code: Many - See 'Attachment 1 - Affected Product List' Product Description: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU Catalog Number: 8065000093 UDI-DI code: 380650000934 Lot Numbers: 177FE4 1782JM 178DEX 178TCV 179EP4 179EP3 179U0P 17AVMM 17AVMN 17AVML 17AVMP Product Description: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000095 UDI-DI code: 380650000958 Lot Numbers: 1782JU 1782JT 178DF2 178TCY 178TD0 1792YF 1792YE 179U0R 17A4XT 17A4XU 17AFXT 17AVMT 17AVMU 17AVMV 17AVMW 17AVMX 17CNVC Product Description: 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU Catalog Number: 8065000096 UDI-DI code: 380650000965 Lot Numbers: 1782JV 178DF4 17A4XV Product Description: TOTAL PLUS,23G,10K VALVE STD Catalog Number: 8065752435 UDI-DI code: 380657524358 Lot Numbers: 1754N7 1754NC 175M43 1762KH 176CCJ 176CCK 176WU8 176WU9 17769X 1782HM 1782HN 178T9K 179EEV 179TY3 179TY4 17A4WX 17C7FM 17C7FL Product Description: TOTAL PLUS,23GA,10K VALVE WD Catalog Number: 8065752436 UDI-DI code: 380657524365 Lot Numbers: 1762KJ 176WUA 17769Y 177FDH 1782HP 178DE8 178T9N 179EEX 179EEY 17C7FK Product Description: TOTAL PLUS,25+,10K VALVE STD Catalog Number: 8065752437 UDI-DI code: 380657524372 Lot Numbers: 1754NK 1754NL 1754NM 1754TC 1754TD 1754TE 1754TF 1754TH 175M45 175M46 175M47 175M44 1762KK 1762KL 1762KM 1762KN 176CCR 176CCL 176CCM 176CCN 176CCP 176WUD 1776A4 1776A5 1776A6 177FDJ 177FDK 177FDL 177FDM 177TUP 177TUR 177TUT 1782HU 1782HV 1782HW 178DEA 178DEC 178T9V 178T9W 178TD4 17930F 17930H 179EF3 179EF2 179TY6 179TY7 179TY8 179TY9 179TYA 179TYC 179TYD 17A4X5 17A4X6 17A4X2 17A4X3 17A4X1 17AFWE 17AFWH 17AFWP 17AFWR 17AFWY 17AFX0 17AFWX 17C7FD 17C7FE Product Description: TOTAL PLUS,25+,10K VALVE WD Catalog Number: 8065752438 UDI-DI code: 380657524389 Lot Numbers: 175M48 1762KR 1762KT 176CCT 176WUE 1776AD 177FDN 1782HY 178TA1 178TA2 178TA3 179EF6 179EF7 179TYJ 17A4X9 17AFX6 17C7FC 17CNUT Product Description: TOTAL PLUS,27+,10K VALVE STD Catalog Number: 8065752439 UDI-DI code: 380657524396 Lot Numbers: 176CCU 1776AE Product Description: 23G CMB PAK 10K CPM,V,WA 0.9 Catalog Number: 8065752449 UDI-DI code: 380657524495 Lot Numbers: 178DEK 178DEL 179TYM 17A4XF 17C7E9 Product Description: 25+ CMB PAK 10K CPM,V,STD 0.9 Catalog Number: 8065752450 UDI-DI code: 380657524501 Lot Numbers: 1782J7 1782J8 1782J5 1782J9 178DEN 178DEP 178TCN 178TCP 17930L 17930M 17930N 178TCR 179EHF 179EHJ 179TYW 179U07 179U02 17A4XH 17A4XP 17AFXF 17AFXA Product Description: 25+ CMB PAK 10K CPM,V,WA 0.9 Catalog Number: 8065752451 UDI-DI code: 380657524518 Lot Numbers: 1782JL 178DER 1792YH 178TCU 179U0K 17A4XR Product Description: 25+TTLPL VPK 20000CPM BEV VAL Catalog Number: 8065753106 UDI-DI code: 380657531066 Lot Numbers: 174P7C 1754RP 1754RR 1754RT 1754RU 175M4N 175M4P 175M4M 1754UY 175M4R 175M4T 175M4U 1762LL 1762LR 1762LP 1762LT 1762LM 1762LN 176CD7 176CD6 176NFD 176NFE 176NFH 176NFJ 176WUW 176WUX 176WV0 176WV1 1776DD 1776DC 177FEF 177FEH 177FEJ 177TVF 177TVH 1782K0 1782K1 1782K2 1782K3 1782K4 178DFW 178DFX 178DFY 178DH0 178RTD 178TD1 178TD2 178TD3 1792YD 179EPE 179EPF 179EPH 179EPJ 179EPK 179EPL 179EPM 179EPN 179EPP 179U14 179U15 179U16 179U17 17A4YP 17A4YM 17A4YN 17A4YR 17AVN6 17AVN9 17AVN7 17AVNE 17C7DW 17C7DX 17C7DY 17C7E0 Product Description: 27+TTLPL VPK 20000CPM BEV VL Catalog Number: 8065753109 UDI-DI code: 380657531097 Lot Numbers: 1762LV 1762LW 1762LX 178DHL 179EPT 179EPU Product Description: 25+ TTL PLUS VPAK 20000CPM BWV Catalog Number: 8065830077 UDI-DI code: 380658300777 Lot Numbers: 1754RH 1754RJ 1754RK 1754RL 1754UW 1754UX 175M4H 175M4J 175M4K 175M4L 1762LH 1762LK 1762LJ 176WUU 176WUV 1776DA 177FEA 177FEC 177TV9 177TVA 1782JW 1782JX 178DF7 178DF8 178DF9 178DFA 178RTC 179EPA 179EPC 179U0V 179U0W 179U0Y 17A4XX 17A4XW 17AVN2 17C7E6 17C7E4 17C7E2 17C7E3 17C7E5
FEI Number 1610287
Recalling Firm/
Manufacturer		 Alcon Research LLC
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information ContactKristen Kellerhals
1-817-5514047
Manufacturer Reason
for Recall		Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 05/01/2025, the firm sent via Overnight FedEx an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that there is a potential for some trays within impacted lots to have damage in the Tyvek cover and compromising the sterility of the products. Customers are instructed: For Standalone Constellation kits- 1. Review inventory to locate, segregate and dispose of affected products 2. Call Alcon Customer Service to arrange for replacement products 3. Forward Post Recall Notice to all department within their organization and to facilities where the product may have been transfer to 4. Post the Recall Notice on or near affected products to ensure awareness of the recall. Alcon will be reinspecting its remaining inventory. Reinspected products that pass inspection will be labeled with a green "QC PASSED" sticker on the packaging. For all Custom Pak kits that contain an impacted Constellation Pak, customers are instructed to: 1. All components inside a Custom Pak are terminal sterilized and Alcon is advising that after an affected Custom Pak is opened, the affected Constellation Pak should be used for that specific surgical case and discarded at the end of the case. Do not save the Constellation Pak for future use. 2. Review their inventory and any unused Customer Pak that contain the affected Constellation Pak, and place the provided stickers to label any affected products. 3. If customer have previously reshelved any affected Constellation Pak, please dispose of them. Any questions or concerns about this matter, call Alcon Customer Service at 1-800-862-5266 or contact your Alcon Sales Representative.
Quantity in Commerce198205
DistributionWorldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Luxembourg, Macao, Malaysia, Malta, Mexico, Moldova, Mongolia, Montenegro, Morocco, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Qatar, Republic of North Macedonia, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MLZ
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