Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
- Company
- Bausch & Lomb Surgical, Inc.
- Recall Initiated
- March 27, 2025
- Posted
- May 2, 2025
- Recall Number
- Z-1680-2025
- Quantity
- 48,237
- Firm Location
- Clearwater, FL
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.
Distribution
Worldwide 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.
Lot / Code Info
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, 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10757770640727, 10757770640734, 10757770640741, 10757770640758, 10757770640765, 10757770640772, 10757770640789, 10757770640796, 10757770640802, 10757770640819, 10757770640826, 10757770640833, 10757770640840, 10757770640857, 10757770640864, 10757770640871, 10757770640888, 10757770640895, 10757770640901, 10757770640918, 10757770640925, 10757770640932, 10757770640949, 10757770640956, 10757770640963, 10757770640970, 10757770640987, 10757770640994, 10757770641007, 10757770641014, 10757770641021, 10757770641038, 10757770641045, 10757770641052, 10757770641069, 10757770641076, 10757770641083, 10757770641090, 10757770641106, 10757770641113, 10757770641120, 10757770641137, 10757770641144, 10757770641151, 10757770641168, 10757770641175, 10757770641182, 10757770641199, 10757770641205, 10757770641212, 10757770641229, 10757770641236, 10757770641243, 10757770641250, 10757770641267, 10757770641274, 10757770641281, 10757770641298, 10757770641304, 10757770641311, 10757770641328, 10757770641335, 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10757770645654, 10757770645661, 10757770645678, 10757770645685, 10757770645692, 10757770645708, 10757770636607
Root Cause
Process control
Action Taken
On 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.