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Class 3 Device Recall Optima |
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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.
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Code Information |
Lot R21000211 |
Recalling Firm/ Manufacturer |
Bausch & Lomb Inc 1400 North Goodman St P.O. Box 30450 Rochester NY 14609
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For Additional Information Contact |
Debra Ketchum 800-344-8815
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Manufacturer Reason for Recall |
Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
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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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