Recall archive / FDA device enforcement
Akreos, SKU: AO60P0300. Akreos intraocular lenses — FDA record Z-2451-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 6, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Reason
- 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.
- Classification
- Class III
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Quantity
- 2
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2451-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AZ, CA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jun 6, 2025
- Center classification date
- Aug 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.