Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass v
FDA device recall Z-0703-03 · posted 2003-04-01 · Terminated
Recall details
- Recalling firm
- Ciba Vision Corporation
- Reason for recall
- The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
- Action taken
- The recall is being conducted to the wholesale level. The firm began contacting consignees via traceable mail on/about 3/17/2003. Included was A Business Reply Form and pre-paid airbill to return the product currently in inventory and the completed form. All inventory and returned product will be destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPL
- Quantity affected
- 29,821 units
- Distribution
- Nationwide, Canada and Puerto Rico.
- Date initiated
- 2003-03-17
- Date posted
- 2003-04-01
- Date terminated
- 2004-04-07
- Location
- Duluth, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K003071) | Ciba Vision Corporation | 2000-12-13 |