Class 3 Device Recall Optima

• Date Initiated by Firm: November 26, 2002
• Date Posted: December 19, 2002
• Recall Status: Terminated 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/ 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: 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

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.