Akreos — Class III medical device recall Z-2451-2025
Ongoing recall by Bausch & Lomb Surgical, Inc., reported 2025-09-03, distributed in AZ, CA. An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Impl
| Recall number | Z-2451-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb Surgical, Inc., Clearwater, FL, United States |
| Recall initiated | 2025-06-06 |
| Classified | 2025-08-26 |
| Reported by FDA | 2025-09-03 |
| Distributed | AZ, CA |
| Quantity | 2 |
| UPC / GTIN / UDI-DI | 10757770501783 |
| Lot numbers | 1Q29212 |
| Serial numbers | 1Q29212006, 1Q29212010 |
Product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2451-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.