Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.
This recall has been terminated (originally issued September 9, 2009).
- Company
- Bausch & Lomb Inc
- Recall Initiated
- December 8, 2008
- Posted
- September 9, 2009
- Terminated
- November 5, 2009
- Recall Number
- Z-1911-2009
- Quantity
- 158
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.
Distribution
Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom.
Lot / Code Info
Lot Numbers: 1829803, 1829803, 1829814, 1829823 and 1829824.
Root Cause
Release of Material/Component prior to receiving test results
Action Taken
All consignees were notified via phone, telefax and letter. Products are to be returned to Bausch & Lomb's European Logistics Center (ELC) for destruction. Direct questions to Bausch and Lomb, Inc. by calling 1-585-338-6612.