Official recall record
Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-06-06
- Country of alert
- United States
- Alert level
- Class III
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10757770501783
- Brand on record
- Bausch & Lomb Surgical, Inc.
- Product category
- Medical Device
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.