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U.S. Department of Health and Human Services

Class 3 Device Recall Optima

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  Class 3 Device Recall Optima see related information
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
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/
Bausch & Lomb Inc
1400 North Goodman St
P.O. Box 30450
Rochester NY 14609
For Additional Information Contact Debra Ketchum
Manufacturer Reason
for Recall
Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
FDA Determined
Cause 2
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

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.