Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Ster
FDA device recall Z-0827-03 · posted 2003-05-15 · Terminated
Recall details
- Recalling firm
- Ciba Vision Corporation
- Reason for recall
- Lenses may be labeled with the incorrect axis.
- Action taken
- Consignees were notified by letter via Airborne express mail on May 6, 2003. They were advised to return any of the affected lots remaining in their inventory to CIBA Vision, with the letter, a business reply form and a pre-paid air bill sticker provided by the recalling firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPL
- Quantity affected
- 8, 572 packs (181, 440 lenses)
- Distribution
- The product was distributed to various wholesalers (original consignees) Nationwide, Canada and Europe.
- Date initiated
- 2003-05-06
- Date posted
- 2003-05-15
- Date terminated
- 2003-11-18
- 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 |
|---|---|---|
| DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENS (K963487) | Ciba Vision Corporation | 1996-11-27 |