Summary
The FDA issued a Class III for Akreos, SKU: AO60P0300. Akreos intraocular lenses by Bausch & Lomb Surgical, Inc.. Reason: An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens co.
Details
Source
Device Recall
External ID
Z-2451-2025
Action Date
2025-09-03
Status
Ongoing
Category
device
Product Description
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Lot/Code Info: UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Quantity Affected: 2
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.
Distribution
US: AZ, CA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-06
Company
Clearwater, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bausch & Lomb Surgical, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bausch & Lomb Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bausch & Lomb Surgical, Inc. have FDA actions?
Bausch & Lomb Surgical, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2451-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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