AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240
FDA device recall Z-0129-2011 · posted 2010-11-02 · Terminated
Recall details
- Recalling firm
- Abbott Medical Optics Inc (AMO)
- Reason for recall
- The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.
- Action taken
- AMO prepared and issued on July 28, 2010 both a customer and distributor notification letter as part of their customer communication process. The letter informed the customers of the reason for recall, the products involved, the hazard involved and actions to be taken regarding the affected products. Customer with questions related to the COMPLETE Multi-Purpose Solution and/or Total Care (1) Contact Lens Solution return process, were instructed to contact an AMO Customer Service Representative at 1800 931 663.
- Root cause
- Pending
- Status
- Terminated
- Product code
- LPN
- Quantity affected
- 34,080 units
- Distribution
- International Distribution Only -- United Kingdom, Lebanon, Dubai, Bahrain, Russia, Kazakhstan, Ireland, and France.
- Date initiated
- 2010-07-23
- Date posted
- 2010-11-02
- Date terminated
- 2011-10-13
- 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 (K014202) | Allergan, Inc. | 2002-02-20 |