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Terminated

Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution (Japan only)

FDA Recall Z-0348-2007 · Posted 2007-03-01

Recalling FirmAdvanced Medical Optics, Inc.
Recall StatusTerminated
Product CodeLPN
Date Initiated2006-09-15
Date Terminated2010-02-17
Product Quantity182,678 units for all US products, 2,943,207 units worldwide

Reason for Recall

Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.

Firm Action

Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.

Root Cause

Other

Distribution Pattern

Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.

Official Source

View FDA Recall →

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

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