Recall Z-0346-2007 ยท LPN Accessories, Soft Lens Products
Advanced Medical Optics, Inc.
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)
| Date | Mar 1, 2007 (initiated Sep 15, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981168 | COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS Allergan, Inc., Sep 1, 1998 |