Bausch & Lomb Surgical, Inc. recalls Intraocular Lens. enVista Envy IOL
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Lot / code information
- UDI
enVista Envy IOL (ENU)/3Q24764, 3Q24935, 3Q25113, 3Q25833, 3Q26256, 3Q26257 — +1543 moreShow all
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, 3Q3 …
What the firm is doing
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.
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1680-2025
- FDA device classification · MFKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 886.3600The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Bausch & Lomb Surgical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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