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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
COMPLETE Multi-Purpose, 10 Minute, Comfort 8 in 1, Comfort Plus, and Protec		see related information
Date Posted March 01, 2007
Recall Number Z-0346-2007
Product 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)
Code Information No US distribution
Recalling Firm/
Manufacturer		 Advanced Medical Optics, Inc.
1700 E Saint Andrew Pl
Santa Ana, California 92705-4933
For Additional Information Contact Sandra F. Selvaggi
714-247-8656
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.
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.
Quantity in Commerce 182,678 units for all US products, 2,943,207 units worldwide
Distribution Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.
 
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