COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute (Japan o
FDA device recall Z-0346-2007 · posted 2007-03-01 · Terminated
Recall details
- Recalling firm
- Advanced Medical Optics, Inc.
- 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 taken
- 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
- Status
- Terminated
- Product code
- LPN
- Quantity affected
- 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.
- Date initiated
- 2006-09-15
- Date posted
- 2007-03-01
- Date terminated
- 2010-02-17
- Location
- Santa Ana, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS (K981168) | Allergan, Inc. | 1998-09-01 |