Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All mod...
FDA Device Recall #Z-1680-2025 — Class I — March 27, 2025
Recall Summary
| Recall Number | Z-1680-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | March 27, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bausch & Lomb Surgical, Inc. |
| Location | Clearwater, FL |
| Product Type | Devices |
| Quantity | 48,237 |
Product Description
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
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 Pattern
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 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, 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10757770645050, 10757770645067, 10757770645074, 10757770645081, 10757770645098, 10757770645104, 10757770645111, 10757770645128, 10757770645135, 10757770645142, 10757770645159, 10757770645166, 10757770636584, 10757770645173, 10757770645180, 10757770645197, 10757770645203, 10757770645210, 10757770645227, 10757770645234, 10757770645241, 10757770645258, 10757770645265, 10757770645272, 10757770645289, 10757770645296, 10757770645302, 10757770645319, 10757770645326, 10757770645333, 10757770645340, 10757770645357, 10757770645364, 10757770645371, 10757770645388, 10757770645395, 10757770645401, 10757770645418, 10757770645425, 10757770645432, 10757770636591, 10757770645449, 10757770645456, 10757770645463, 10757770645470, 10757770645487, 10757770645494, 10757770645500, 10757770645517, 10757770645524, 10757770645531, 10757770645548, 10757770645555, 10757770645562, 10757770645579, 10757770645586, 10757770645593, 10757770645609, 10757770645616, 10757770645623, 10757770645630, 10757770645647, 10757770645654, 10757770645661, 10757770645678, 10757770645685, 10757770645692, 10757770645708, 10757770636607
Other Recalls from Bausch & Lomb Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2451-2025 | Class III | Akreos, SKU: AO60P0300. Akreos intraocular lenses | Jun 6, 2025 |
| Z-1679-2025 | Class I | Intraocular lens. enVista Monofocal IOL, All mo... | Mar 27, 2025 |
| Z-0519-2021 | Class II | MX60ET (enhanced enVista Toric) enVista¿ One-Pi... | Nov 7, 2020 |
| Z-2552-2020 | Class II | enVista one-piece hydrophobic acrylic toric int... | Jun 9, 2020 |
| Z-0628-2019 | Class II | enVista One Piece Hydrophobic Acrylic Intraocul... | Nov 5, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.