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Intraocular Lens. enVista Envy IOL, All models starting… recallZ-1680-2025 · Bausch & Lomb Surgical, Inc. · initiated Mar 27, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Bausch & Lomb Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company 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 [email protected] 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.

Recall details

Recall number
Z-1680-2025
Status
Open, Classified
Initiated by the company
Mar 27, 2025
Posted by the FDA
May 2, 2025
Recalling firm
Bausch & Lomb Surgical, Inc.
Quantity
48,237
Product code
MFK
FDA submissions
P240005
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.

Product description

Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

Code information (models, lots, serial numbers)

Show the full code information (18k characters)

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, 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Devices named in this recall

566 devices in the FDA device registry whose identifier appears in the recall's code information; the 100 most reported are shown.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96594).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page