Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb
FDA device recall Z-1911-2009 · posted 2009-09-09 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- 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.
- 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.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- 158
- Distribution
- Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom.
- Date initiated
- 2008-12-08
- Date posted
- 2009-09-09
- Date terminated
- 2009-11-05
- Location
- Rochester, NY
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