CLASS III ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
Akreos, SKU: AO60P0300. Akreos intraocular lenses recalled
Bausch & Lomb Surgical is recalling Akreos, SKU: AO60P0300. Akreos intraocular lenses, distributed in Arizona, California. The recall was initiated on 6 Jun 2025 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2451-2025
- FDA event ID
- 97232
- Recalling firm
- Bausch & Lomb Surgical, Clearwater, FL
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 6 Jun 2025
- FDA classified
- 26 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 6 Jun 2025 | Recall initiated by company | |
| 26 Aug 2025 | Classified by FDA | +81 days |
| 3 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Where it was distributed
US: AZ, CA
Questions about this recall
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.
Which lots are affected?
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Where was it sold?
US: AZ, CA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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