FDA Medical devices recall ·
Akreos, SKU: AO60P0300. Akreos intraocular lenses recall
- Recall number
- Z-2451-2025
- Date
- (initiated June 6, 2025)
- Company / brand
- Bausch & Lomb Surgical, Inc.
21 N Park Place Blvd, Clearwater, FL, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 2
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Distribution
US: AZ, CA
States: Arizona California
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-2451-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.