Akreos, SKU: AO60P0300. Akreos intraocular lenses
Reported: September 3, 2025 Initiated: June 6, 2025 #Z-2451-2025
Product Description
Akreos, SKU: AO60P0300. Akreos intraocular lenses
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.
Details
- Recalling Firm
- Bausch & Lomb Surgical, Inc.
- Units Affected
- 2
- Distribution
- US: AZ, CA
- Location
- Clearwater, FL
Frequently Asked Questions
What product was recalled? ▼
Akreos, SKU: AO60P0300. Akreos intraocular lenses. Recalled by Bausch & Lomb Surgical, Inc.. Units affected: 2.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2025. Severity: Low. Recall number: Z-2451-2025.
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