Recall Register

Food, drugs, devices › Firms

Bausch & Lomb Surgical, Inc.

FDA recalling firm · 8 enforcement events · 10 product records · 2013–2025 · FL

Bausch & Lomb Surgical, Inc. has 8 FDA enforcement events on this register (10 product records) between 2013 and 2025: 8 device; the busiest year was 2020 with 2.

13% of its events are Class I; the most common class is Class II (6). 2 events are listed as ongoing; the recalling firm's address is in FL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
6 Jun 2025Akreos, SKU: AO60P0300. Akreos intraocular lensesDeviceClass III1Ongoing
27 Mar 2025Intraocular 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;DeviceClass I2Ongoing
7 Nov 2020MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.DeviceClass II1Terminated
9 Jun 2020enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision.DeviceClass II1Terminated
5 Nov 2018enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.DeviceClass II1Terminated
5 Apr 2017SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic…DeviceClass II1Terminated
26 May 2015Bausch & Lomb SofPort Advanced Optics Aspheric LensDeviceClass II2Terminated
16 Oct 2013Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.DeviceClass II1Terminated

By type and class

Device8
Class II6
Class I1
Class III1

Class I: 13% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for Bausch & Lomb Surgical, Inc. by year initiated.

Questions and answers

How many FDA recalls has Bausch & Lomb Surgical, Inc. had?

8 enforcement events (10 product records) on this register, 2013–2025: 8 device.

Are any Bausch & Lomb Surgical, Inc. recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Bausch & Lomb Surgical, Inc. recalls?

6 Class II, 1 Class I, 1 Class III. 13% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.