Food, drugs, devices › Bausch & Lomb Surgical, Inc.
Device recall: Akreos, SKU: AO60P0300. Akreos intraocular lenses
Bausch & Lomb Surgical, Inc. (Clearwater, FL) initiated this device recall on 6 Jun 2025; FDA lists 1 product record under event 97232, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 2% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. 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
"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."
Distribution
"US: AZ, CA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2451-2025 | Akreos, SKU: AO60P0300. Akreos intraocular lenses | 2 | Class III | Ongoing | 3 Sep 2025 |
Context
Other enforcement events for Bausch & Lomb Surgical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 16 Oct 2013 | Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the | Device | Class II | 1 |
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: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US: AZ, CA"
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.