Akreos, SKU: AO60P0300. Akreos intraocular lenses
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
β οΈ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Bausch & Lomb Surgical, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Product Codes/Lot Numbers:
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Distribution:
Distributed in: US, AZ, CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2451-2025
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