FDAFDA · Food and drugs·Recall number Z-2451-2025
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Published September 3, 2025 · Recall initiated: June 6, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bausch & Lomb Surgical, Inc.
- Distributor
- US: AZ, CA
- Lot
- UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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