Bausch & Lomb Surgical, Inc.

Complete recall history across all FDA and CPSC categories — 10 total recalls

Bausch & Lomb Surgical, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by Bausch & Lomb Surgical, Inc.

Date Product Reason Class
Jun 6, 2025 Akreos, SKU: AO60P0300. Akreos intraocular lenses An off-power error was identified, which resulted in a diopter of 16, rather ... Class III
Mar 27, 2025 Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVist... In response to an increased number of reports of toxic anterior segment syndr... Class I
Mar 27, 2025 Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Env... In response to an increased number of reports of toxic anterior segment syndr... Class I
Nov 7, 2020 MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric ... Product may be missing toric axis marks. Class II
Jun 9, 2020 enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb... The toric axis marks were misaligned (from the expected position in relation ... Class II
Nov 5, 2018 enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for... Cosmetic imperfections on the surface of some lenses. Class II
Apr 5, 2017 SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the foldi... Complaints concerning kinked haptics that were occurring during lens delivery. Class II
May 26, 2015 Bausch & Lomb SofPort Advanced Optics Aspheric Lens Haptics breaking during lens loading and insertion. Class II
May 26, 2015 Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofP... Haptics breaking during lens loading and insertion. Class II
Oct 16, 2013 Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for p... Lens was manufactured with incorrect raw material. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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