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U.S. Department of Health and Human Services

Class 2 Device Recall COMPLETE MoisturePLUS & COMPLETE Amino Moist

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 Class 2 Device Recall COMPLETE MoisturePLUS & COMPLETE Amino Moistsee related information
Date Initiated by FirmSeptember 15, 2006
Date PostedMarch 01, 2007
Recall Status1 Terminated 3 on February 17, 2010
Recall NumberZ-0344-2007
Recall Event ID 36711
Product Classification contact lens solution - Product Code LPN
ProductCOMPLETE MoisturePLUS Multi-Purpose Solution (US and Asia Pacific markets, excluding Japan) & COMPLETE Amino Moist Multi-Purpose Solution (Japan only)
Code Information US Product Number 93184, Lot Numbers: ZB03087, ZB03724, ZB03734, ZB03735, ZB03736 & ZB03739 US Product Number 90104US, Lot Numbers: ZB02710, ZB02714, ZB02718 & ZB02722 US Product Number 90105US, Lot Numbers: ZB02746, ZB02750, ZB02771, ZB02792, ZB02796, ZB02800, ZB02704 & ZB03535
Recalling Firm/
Manufacturer		 Advanced Medical Optics, Inc.
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information ContactSandra F. Selvaggi
714-247-8656
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionBeginning 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 Commerce182,678 units for all US products, 2,943,207 units worldwide
DistributionWorldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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