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Terminated

Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.

FDA Recall Z-1911-2009 · Posted 2009-09-09

Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeHQL
Date Initiated2008-12-08
Date Terminated2009-11-05
Product Quantity158

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.

Firm Action

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

Distribution Pattern

Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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