OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch
FDA device recall Z-0348-03 · posted 2002-12-19 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
- Action taken
- Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPM
- Quantity affected
- 2,081 / 6-packs
- Distribution
- Nationwide distribution.
- Date initiated
- 2002-11-26
- Date posted
- 2002-12-19
- Date terminated
- 2003-06-23
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.