COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute (Japan only), Comfort 8 in 1 Solution (Indonesia only), COMPLETE Comfort Plus All in One Solution (Korea only) & COMPLETE Protec Formula Multi-Purpose Solution (Thailand only)
FDA Recall Z-0346-2007 · Posted 2007-03-01
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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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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