Food, drugs, devices › Bausch & Lomb Surgical, Inc.
Device recall: Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the
FDA enforcement event 67283 is a device recall by Bausch & Lomb Surgical, Inc. of Clearwater, FL, initiated 16 Oct 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 17 Sep 2014. Initiation: voluntary: firm initiated. Bausch & Lomb Surgical, Inc. has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bausch & Lomb Surgical, Inc., Clearwater, FL.
Reason for recall
"Lens was manufactured with incorrect raw material."
Distribution
"Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1062-2014 | Bausch & 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. | 336 IOLs (283 IOLs in the US, 53 IOLs outside the US) | Class II | Terminated | 26 Feb 2014 |
Context
Other enforcement events for Bausch & Lomb Surgical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Jun 2025 | Akreos, SKU: AO60P0300. Akreos intraocular lenses | Device | Class III | 1 |
| 27 Mar 2025 | Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; e | Device | Class I | 2 |
| 7 Nov 2020 | MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is i | Device | Class II | 1 |
| 9 Jun 2020 | enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary | Device | Class II | 1 |
| 5 Nov 2018 | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction | Device | Class II | 1 |
| 5 Apr 2017 | SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or | Device | Class II | 1 |
| 26 May 2015 | Bausch & Lomb SofPort Advanced Optics Aspheric Lens | Device | Class II | 2 |
All 8 events for Bausch & Lomb Surgical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Lens was manufactured with incorrect raw material."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.