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U.S. Department of Health and Human Services

Class 1 Device Recall

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 Class 1 Device Recallsee related information
Date Initiated by FirmMarch 27, 2025
Date PostedMay 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1680-2025
Recall Event ID 96594
PMA NumberP240005 
Product Classification Lens, multifocal intraocular - Product Code MFK
ProductIntraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Code Information Description/Lots/UDI-DI: enVista Envy IOL (ENU)/3Q24764, 3Q24935, 3Q25113, 3Q25833, 3Q26256, 3Q26257, 3Q26538, 3Q26601, 3Q26603, 3Q26604, 3Q26679, 3Q26680, 3Q27353, 3Q27447, 3Q27457, 3Q27905, 3Q27907, 3Q28001, 3Q28002, 3Q28124, 3Q28125, 3Q28801, 3Q28901, 3Q28903, 3Q28904, 3Q28905, 3Q28906, 3Q29020, 3Q29021, 3Q29205, 3Q29266, 3Q29301, 3Q29302, 3Q29304, 3Q29305, 3Q29306, 3Q29401, 3Q29403, 3Q29405, 3Q29406, 3Q29545, 3Q29547, 3Q29548, 3Q29636, 3Q29637, 3Q29835, 3Q29837, 3Q30210, 3Q30310, 3Q30311, 3Q33702, 3Q33822, 3Q33918, 3Q33921, 3Q33924, 3Q33925, 3Q33928, 3Q34031, 3Q34034, 3Q34205, 3Q35006, 3Q35733, 3Q35735, 3Q35736, 3Q35738, 3Q35813, 3R01610, 3R01611, 3R02532, 3R02534, 3R02536, 3R02537, 3R02540, 3R02542, 3R02551, 3R02553, 3R02608, 3R02749, 3R02750, 3R02846, 3R03533, 3R03534, 3R03536, 3R03804, 3R03805, 3R03806, 3R04414, 3R04533, 3R05051, 3R05411, 3Q24749, 3Q24750, 3Q24751, 3Q24756, 3Q24763, 3Q24765, 3Q24766, 3Q24837, 3Q24842, 3Q24934, 3Q25115, 3Q25116, 3Q25117, 3Q25118, 3Q25119, 3Q25421, 3Q25422, 3Q25423, 3Q25424, 3Q25506, 3Q25834, 3Q25922, 3Q25923, 3Q26525, 3Q26527, 3Q26539, 3Q26602, 3Q26605, 3Q27252, 3Q27321, 3Q27322, 3Q27323, 3Q27324, 3Q27354, 3Q27456, 3Q27458, 3Q27906, 3Q27908, 3Q28003, 3Q28004, 3Q28011, 3Q28012, 3Q28802, 3Q29017, 3Q29018, 3Q29022, 3Q29203, 3Q29204, 3Q29303, 3Q29402, 3Q29404, 3Q29546, 3Q29550, 3Q29635, 3Q30211, 3Q30213, 3Q32503, 3Q33816, 3Q33817, 3Q33818, 3Q33819, 3Q33820, 3Q33821, 3Q33823, 3Q33920, 3Q33922, 3Q33926, 3Q33927, 3Q33929, 3Q34032, 3Q34033, 3Q34201, 3Q34202, 3Q34203, 3Q34204, 3Q34901, 3Q34903, 3Q35028, 3Q35031, 3Q35734, 3Q35812, 3R01612, 3R02136, 3R02535, 3R02539, 3R02541, 3R02543, 3R02601, 3R02602, 3R02603, 3R02607, 3R02710, 3R02711, 3R02845, 3R02848, 3R03411, 3R03502, 3R03643, 3R04411, 3R04412, 3R04531, 3R05048, 3R05049, 3R05052, 3R05627/ 10757770636478, 10757770637017, 10757770637031, 10757770637055, 10757770637079, 10757770637543, 10757770637093, 10757770637109, 10757770637536, 10757770637116, 10757770637123, 10757770637130, 10757770637147, 10757770637154, 10757770637161, 10757770637178, 10757770637185, 10757770637192, 10757770637208, 10757770637215, 10757770637222, 10757770637239, 10757770637246, 10757770637253, 10757770636485, 10757770637550, 10757770637277, 10757770637284, 10757770637291, 10757770637307, 10757770637314, 10757770637321, 10757770637338, 10757770637345, 10757770637352, 10757770637369, 10757770637376, 10757770637383, 10757770637390, 10757770637406, 10757770637413, 10757770637420, 10757770637437, 10757770637444, 10757770637451, 10757770637468, 10757770637475, 10757770637482, 10757770637499, 10757770637505, 10757770637512, 10757770637529, 10757770636492; enVista Envy Toric IOL (ETNU)/3Q25926, 3Q25930, 3Q26240, 3Q26426, 3Q26431, 3Q26435, 3Q26436, 3Q26440, 3Q26441, 3Q26621, 3Q26726, 3Q26727, 3Q26731, 3Q26819, 3Q26820, 3Q26910, 3Q26928, 3Q27216, 3Q27217, 3Q27219, 3Q27221, 3Q27223, 3Q27249, 3Q27250, 3Q27251, 3Q27264, 3Q27327, 3Q27330, 3Q27505, 3Q27506, 3Q27518, 3Q27742, 3Q27912, 3Q28007, 3Q28008, 3Q28009, 3Q28010, 3Q28013, 3Q28134, 3Q28136, 3Q28721, 3Q28809, 3Q28818, 3Q28908, 3Q28909, 3Q28910, 3Q29208, 3Q29210, 3Q29212, 3Q29409, 3Q29517, 3Q29642, 3Q29922, 3Q29959, 3Q29961, 3Q30005, 3Q30136, 3Q30137, 3Q30138, 3Q30139, 3Q30208, 3Q30309, 3Q30453, 3Q30454, 3Q30517, 3Q30646, 3Q30647, 3Q30725, 3Q30741, 3Q30744, 3Q30803, 3Q31102, 3Q31107, 3Q31108, 3Q31509, 3Q31540, 3Q31541, 3Q31543, 3Q31865, 3Q31866, 3Q31929, 3Q32003, 3Q32004, 3Q32005, 3Q32009, 3Q32010, 3Q32206, 3Q32209, 3Q32211, 3Q32330, 3Q32331, 3Q32439, 3Q32443, 3Q32525, 3Q32529, 3Q32530, 3Q32606, 3Q32735, 3Q32737, 3Q32743, 3Q32842, 3Q32844, 3Q32846, 3Q32851, 3Q32931, 3Q32932, 3Q33014, 3Q33015, 3Q33128, 3Q33203, 3Q33505, 3Q33508, 3Q33545, 3Q33604, 3Q33613, 3Q33721, 3Q33902, 3Q34121, 3Q34256, 3Q34258, 3Q34315, 3Q35117, 3Q35335, 3Q35430, 3Q35431, 3Q35432, 3Q35433, 3Q35532, 3Q35557, 3Q35624, 3Q35625, 3Q35626, 3Q35628, 3Q35631, 3Q35704, 3Q35741, 3Q35758, 3Q35942, 3R00250, 3R01019, 3R01604, 3R01905, 3R02801, 3R03722, 3R03807, 3R04116, 3Q24946, 3Q25501, 3Q25605, 3Q25606, 3Q25703, 3Q25704, 3Q25722, 3Q25723, 3Q25725, 3Q25740, 3Q25741, 3Q25835, 3Q25836, 3Q25838, 3Q25839, 3Q25924, 3Q25925, 3Q25928, 3Q25931, 3Q25932, 3Q25933, 3Q26003, 3Q26004, 3Q26011, 3Q26012, 3Q26013, 3Q26059, 3Q26060, 3Q26061, 3Q26062, 3Q26063, 3Q26075, 3Q26076, 3Q26077, 3Q26078, 3Q26079, 3Q26080, 3Q26101, 3Q26102, 3Q26211, 3Q26212, 3Q26213, 3Q26214, 3Q26215, 3Q26216, 3Q26217, 3Q26230, 3Q26231, 3Q26232, 3Q26233, 3Q26234, 3Q26235, 3Q26236, 3Q26237, 3Q26238, 3Q26239, 3Q26241, 3Q26259, 3Q26260, 3Q26320, 3Q26321, 3Q26322, 3Q26323, 3Q26324, 3Q26325, 3Q26326, 3Q26327, 3Q26427, 3Q26428, 3Q26430, 3Q26432, 3Q26433, 3Q26434, 3Q26437, 3Q26439, 3Q26442, 3Q26443, 3Q26523, 3Q26524, 3Q26620, 3Q26623, 3Q26624, 3Q26625, 3Q26626, 3Q26721, 3Q26722, 3Q26723, 3Q26724, 3Q26725, 3Q26728, 3Q26729, 3Q26730, 3Q26732, 3Q26821, 3Q26822, 3Q26823, 3Q26824, 3Q26901, 3Q26902, 3Q26903, 3Q26904, 3Q26905, 3Q26908, 3Q26909, 3Q26930, 3Q27218, 3Q27220, 3Q27222, 3Q27224, 3Q27225, 3Q27248, 3Q27256, 3Q27265, 3Q27325, 3Q27326, 3Q27328, 3Q27329, 3Q27331, 3Q27332, 3Q27333, 3Q27334, 3Q27335, 3Q27350, 3Q27351, 3Q27352, 3Q27449, 3Q27501, 3Q27502, 3Q27503, 3Q27504, 3Q27516, 3Q27517, 3Q27519, 3Q27624, 3Q27625, 3Q27626, 3Q27627, 3Q27628, 3Q27629, 3Q27743, 3Q27744, 3Q27745, 3Q27909, 3Q27910, 3Q27911, 3Q27913, 3Q27914, 3Q28005, 3Q28006, 3Q28014, 3Q28127, 3Q28129, 3Q28130, 3Q28131, 3Q28132, 3Q28133, 3Q28135, 3Q28228, 3Q28719, 3Q28806, 3Q28807, 3Q28808, 3Q28810, 3Q28907, 3Q28911, 3Q29104, 3Q29105, 3Q29106, 3Q29128, 3Q29129, 3Q29130, 3Q29206, 3Q29207, 3Q29209, 3Q29211, 3Q29213, 3Q29214, 3Q29307, 3Q29308, 3Q29309, 3Q29310, 3Q29311, 3Q29312, 3Q29407, 3Q29408, 3Q29410, 3Q29411, 3Q29412, 3Q29451, 3Q29452, 3Q29515, 3Q29516, 3Q29518, 3Q29519, 3Q29520, 3Q29522, 3Q29523, 3Q29643, 3Q29644, 3Q29645, 3Q29705, 3Q29706, 3Q29707, 3Q29708, 3Q29709, 3Q29710, 3Q29711, 3Q29712, 3Q29713, 3Q29801, 3Q29838, 3Q29920, 3Q29921, 3Q29923, 3Q29957, 3Q29958, 3Q29960, 3Q30001, 3Q30002, 3Q30003, 3Q30004, 3Q30140, 3Q30201, 3Q30202, 3Q30203, 3Q30204, 3Q30205, 3Q30206, 3Q30207, 3Q30209, 3Q30301, 3Q30302, 3Q30303, 3Q30305, 3Q30306, 3Q30307, 3Q30308, 3Q30403, 3Q30434, 3Q30435, 3Q30437, 3Q30439, 3Q30440, 3Q30515, 3Q30516, 3Q30520, 3Q30523, 3Q30635, 3Q30636, 3Q30637, 3Q30648, 3Q30649, 3Q30740, 3Q30742, 3Q30743, 3Q30746, 3Q30747, 3Q30748, 3Q30749, 3Q30801, 3Q30812, 3Q30814, 3Q30815, 3Q30816, 3Q30817, 3Q30818, 3Q30902, 3Q30903, 3Q30904, 3Q30926, 3Q30927, 3Q30939, 3Q30940, 3Q30941, 3Q30942, 3Q31006, 3Q31007, 3Q31008, 3Q31042, 3Q31043, 3Q31053, 3Q31054, 3Q31101, 3Q31103, 3Q31104, 3Q31105, 3Q31106, 3Q31109, 3Q31110, 3Q31213, 3Q31214, 3Q31218, 3Q31219, 3Q31237, 3Q31238, 3Q31239, 3Q31450, 3Q31507, 3Q31508, 3Q31539, 3Q31542, 3Q31544, 3Q31601, 3Q31604, 3Q31605, 3Q31606, 3Q31607, 3Q31608, 3Q31609, 3Q31610, 3Q31611, 3Q31715, 3Q31716, 3Q31717, 3Q31718, 3Q31719, 3Q31720, 3Q31721, 3Q31842, 3Q31843, 3Q31844, 3Q31867, 3Q31868, 3Q31928, 3Q31930, 3Q31931, 3Q31932, 3Q31933, 3Q32001, 3Q32002, 3Q32006, 3Q32007, 3Q32008, 3Q32011, 3Q32012, 3Q32037, 3Q32128, 3Q32129, 3Q32130, 3Q32131, 3Q32155, 3Q32156, 3Q32157, 3Q32158, 3Q32159, 3Q32160, 3Q32201, 3Q32202, 3Q32203, 3Q32204, 3Q32205, 3Q32207, 3Q32208, 3Q32210, 3Q32212, 3Q32328, 3Q32329, 3Q32408, 3Q32409, 3Q32410, 3Q32411, 3Q32412, 3Q32440, 3Q32441, 3Q32442, 3Q32444, 3Q32506, 3Q32521, 3Q32522, 3Q32523, 3Q32524, 3Q32526, 3Q32527, 3Q32528, 3Q32607, 3Q32704, 3Q32738, 3Q32739, 3Q32740, 3Q32741, 3Q32742, 3Q32744, 3Q32745, 3Q32843, 3Q32845, 3Q32847, 3Q32848, 3Q32849, 3Q32850, 3Q32929, 3Q32930, 3Q32933, 3Q32934, 3Q32935, 3Q32936, 3Q32937, 3Q33004, 3Q33008, 3Q33009, 3Q33010, 3Q33011, 3Q33012, 3Q33013, 3Q33016, 3Q33017, 3Q33018, 3Q33019, 3Q33101, 3Q33102, 3Q33103, 3Q33129, 3Q33130, 3Q33131, 3Q33132, 3Q33133, 3Q33134, 3Q33204, 3Q33206, 3Q33207, 3Q33208, 3Q33503, 3Q33504, 3Q33506, 3Q33507, 3Q33543, 3Q33544, 3Q33546, 3Q33548, 3Q33605, 3Q33606, 3Q33607, 3Q33611, 3Q33614, 3Q33718, 3Q33719, 3Q33720, 3Q33722, 3Q33723, 3Q33731, 3Q33732, 3Q33824, 3Q33825, 3Q33826, 3Q33827, 3Q33828, 3Q33829, 3Q33901, 3Q34122, 3Q34123, 3Q34124, 3Q34125, 3Q34126, 3Q34127, 3Q34209, 3Q34210, 3Q34211, 3Q34257, 3Q34316, 3Q34317, 3Q34319, 3Q34320, 3Q34321, 3Q34323, 3Q34324, 3Q34325, 3Q34326, 3Q34327, 3Q34328, 3Q34329, 3Q34330, 3Q34331, 3Q34334, 3Q34335, 3Q34336, 3Q34431, 3Q34432, 3Q34436, 3Q34438, 3Q34440, 3Q34516, 3Q34518, 3Q34521, 3Q34522, 3Q34523, 3Q34524, 3Q34527, 3Q34528, 3Q34529, 3Q34530, 3Q34532, 3Q34536, 3Q34537, 3Q34538, 3Q34628, 3Q34633, 3Q34712, 3Q34713, 3Q34715, 3Q34716, 3Q34719, 3Q34720, 3Q34729, 3Q34732, 3Q34745, 3Q34828, 3Q34831, 3Q34832, 3Q34833, 3Q34835, 3Q34836, 3Q34837, 3Q34839, 3Q34840, 3Q34842, 3Q34843, 3Q34845, 3Q34913, 3Q34914, 3Q34916, 3Q34919, 3Q34921, 3Q35022, 3Q35118, 3Q35119, 3Q35120, 3Q35122, 3Q35123, 3Q35126, 3Q35127, 3Q35174, 3Q35213, 3Q35217, 3Q35220, 3Q35223, 3Q35225, 3Q35226, 3Q35336, 3Q35337, 3Q35340, 3Q35341, 3Q35342, 3Q35346, 3Q35348, 3Q35350, 3Q35408, 3Q35429, 3Q35527, 3Q35528, 3Q35529, 3Q35530, 3Q35531, 3Q35534, 3Q35535, 3Q35536, 3Q35559, 3Q35560, 3Q35627, 3Q35629, 3Q35630, 3Q35703, 3Q35739, 3Q35740, 3Q35750, 3Q35842, 3Q35936, 3Q35937, 3Q35938, 3Q35939, 3Q35941, 3R00247, 3R00248, 3R00254, 3R00324, 3R00510, 3R00601, 3R00603, 3R00618, 3R00713, 3R01020, 3R01111, 3R01201, 3R01416, 3R01519, 3R01602, 3R01605, 3R01722, 3R01724, 3R01903, 3R02301, 3R02304, 3R02309, 3R02310, 3R02401, 3R02402, 3R02409, 3R02411, 3R02421, 3R02422, 3R02424, 3R02441, 3R02442, 3R02443, 3R02444, 3R02446, 3R02447, 3R02448, 3R02450, 3R02544, 3R02548, 3R02728, 3R02802, 3R02821, 3R02824, 3R02826, 3R03034, 3R03036, 3R03037, 3R03038, 3R03039, 3R03040, 3R03105, 3R03106, 3R03134, 3R03135, 3R03137, 3R03139, 3R03140, 3R03141, 3R03233, 3R03234, 3R03301, 3R03302, 3R03505, 3R03506, 3R03507, 3R03720, 3R03721, 3R03723, 3R03808, 3R03812, 3R04115, 3R04342, 3R04746, 3R05032, 3R05141/ 10757770640000, 10757770640017, 10757770640024, 10757770640031, 10757770640048, 10757770640055, 10757770640574, 10757770640062, 10757770640079, 10757770640086, 10757770640093, 10757770640109, 10757770640116, 10757770640123, 10757770640130, 10757770640147, 10757770640154, 10757770640161, 10757770640178, 10757770640185, 10757770640192, 10757770640208, 10757770640215, 10757770640222, 10757770640239, 10757770640246, 10757770640253, 10757770640260, 10757770640277, 10757770640284, 10757770640291, 10757770640307, 10757770640314, 10757770640321, 10757770640338, 10757770640345, 10757770640352, 10757770640369, 10757770640376, 10757770640383, 10757770640390, 10757770640406, 10757770640413, 10757770640420, 10757770640437, 10757770640444, 10757770640451, 10757770640468, 10757770640475, 10757770640482, 10757770640499, 10757770640505, 10757770640512, 10757770640529, 10757770640536, 10757770640543, 10757770640550, 10757770640567, 10757770640581, 10757770640598, 10757770640604, 10757770640611, 10757770640628, 10757770640635, 10757770640642, 10757770640659, 10757770640666, 10757770640673, 10757770640680, 10757770640697, 10757770640703, 10757770640710, 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FEI Number 1119279
Recalling Firm/
Manufacturer		 Bausch & Lomb Surgical, Inc.
21 N Park Place Blvd
Clearwater FL 33759-3917
For Additional Information Contact
727-724-6600
Manufacturer Reason
for Recall		In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
FDA Determined
Cause 2		Process control
ActionOn 3/27/2025, a news release was published informing customers that the firm will send out detailed instructions for what to do with any stock on hand. On 4/4/2025, the news release was updated and customers were also informed in a recall notice of the following: For Patients: Cataract surgery patients experiencing eye discomfort should contact their eyecare professional immediately. For Eyecare Professionals: Continue to closely monitor cataract surgery patients for at least 48 hours after surgery. Please instruct patients with new or worsening symptoms to contact your office immediately. Customers were asked to do the following: 1) Quarantine and do not use affected products. 2) Complete and return the acknowledgment form with returned devices or if there are no affected devices to return email the form to BLSurgCustSvc@Bausch.com 3) Provide this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (as appropriate). Please transfer this notice to other organizations on which this action has an impact (as appropriate). Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. 4) All reported cases of TASS to date have occurred within 12 - 48 hours after eye surgery. Rare cases of TASS could have delayed onset, so we request post-operative patient care protocols be followed to closely monitor patients who have received an intraocular lens impacted by this recall. Firm is investigating to identify the root cause of the issue. If you have any questions, or to make a report, contact our Customer Care team at (800) 338-2020, option 9 or 1. On 5/1/2025, revised recall notices were sent informing customers that the firm is reducing the recall scope.
Quantity in Commerce48,237
DistributionWorldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.
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.
PMA DatabasePMAs with Product Code = MFK
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