Bausch & Lomb Surgical, Inc.: Device Recall

Recall Details

Recall Number

Z-1679-2025

Classification

Class I

Product Type

Device

Recalling Firm

Bausch & Lomb Surgical, Inc.

Status

Ongoing

Date Initiated

03/27/2025

Location

Clearwater, FL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

236,840

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.

Product Description

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

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.

Other Recalls by Bausch & Lomb Surgical, Inc.

• Class III: Low Risk 06/06/2025
  An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
• Class I: Dangerous 03/27/2025
  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.

View all recalls by Bausch & Lomb Surgical, Inc. →