| Class 3 Device Recall Optima |  |
Date Initiated by Firm | November 26, 2002 |
Date Posted | December 19, 2002 |
Recall Status1 |
Terminated 3 on June 23, 2003 |
Recall Number | Z-0348-03 |
Recall Event ID |
25105 |
Product Classification |
Lenses, Soft Contact, Extended Wear - Product Code LPM
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Product | OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692.
Each box contains six lenses. |
Code Information |
Lot R21000211 |
Recalling Firm/ Manufacturer |
Bausch & Lomb Inc 1400 North Goodman St P.O. Box 30450 Rochester NY 14609
|
For Additional Information Contact | Debra Ketchum 800-344-8815 |
Manufacturer Reason for Recall | Lenses labeled as -2.25 diopter contain -0.75 diopter lenses. |
FDA Determined Cause 2 | Other |
Action | Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot. |
Quantity in Commerce | 2,081 / 6-packs |
Distribution | Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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