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U.S. Department of Health and Human Services

Class 2 Device Recall Krystal Klear Rinse

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 Class 2 Recall
Krystal Klear Rinse
see related information
Date Posted March 01, 2007
Recall Status1 Terminated on February 17, 2010
Recall Number Z-0345-2007
Recall Event ID 36711
Premarket Notification
510(K) Numbers
K014202  K981168 
Product Classification Accessories, Soft Lens Products - Product Code LPN
Product Krystal Klear Rinse (China only)
Code Information No US distribution
Recalling Firm/
Advanced Medical Optics, Inc.
1700 E Saint Andrew Pl
Santa Ana, California 92705-4933
For Additional Information Contact Sandra F. Selvaggi
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
PRODUCTION CONTROLS: Equipment Maintenance
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.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LPN and Original Applicant = ALLERGAN, INC.