The Recall Desk
ModerateFDA (Devices)·Z-2451-2025·Announced 2025-09-03

Intraocular lenses with incorrect power recalled for vision impairment risk

Bausch & Lomb is recalling Akreos intraocular lenses due to a manufacturing error that resulted in incorrect lens power (16 diopters instead of 3), which could cause vision problems requiring optical or surgical correction.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This Class III recall involves a manufacturing defect with no reported illnesses or injuries. While the optical power error creates a real risk of functional visual impairment that could require corrective intervention, it is not an acute safety hazard.

Plain-English summary

Bausch & Lomb Surgical, Inc. is recalling Akreos intraocular lenses (SKU: AO60P0300) distributed in Arizona and California. The recall affects two units from Lot 1Q29212 with serial numbers 1Q29212006 and 1Q29212010.

An off-power manufacturing error resulted in lenses with an optical power of 16 diopters instead of the intended 3 diopters. Implantation of these affected lenses could result in functional visual impairment or reduction in visual acuity, potentially requiring optical or surgical correction.

If you believe you have been affected by this recall, contact your eye care provider or Bausch & Lomb Surgical, Inc. immediately.

The recalled product

Product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Manufacturer
Bausch & Lomb Surgical, Inc.
Hazard
  • manufacturing-defect
  • lens-power-error
  • visual-impairment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI-DI: 10757770501783
  • Lot: 1Q29212
  • Serial Numbers: 1Q29212006 and 1Q29212010

Distribution

Distributed in 2 states:

  • AZ
  • CA