Class 3 Device Recall

• Date Initiated by Firm: February 04, 2005
• Date Posted: February 16, 2005
• Recall Status: Terminated on October 28, 2005
• Recall Number: Z-0544-05
• Recall Event ID: 31043
• Product Classification: Lenses, Soft Contact, Daily Wear - Product Code LPL
• Product: SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with -3.25 DS, -1.25DC, 170 degree Axis. Firm on label: Manufactured by Bausch & Lomb, Waterford, Ireland.
• Code Information: Carton lot W44090230; Blister Lot W44089478
• Recalling Firm/ Manufacturer: Bausch & Lomb Inc; 1400 North Goodman Street; Rochester NY 14609-3547
• For Additional Information Contact: Anne Zavertnik; 800-344-8815
• Manufacturer Reason for Recall: Portion of lot contains lenses with incorrect refractive power.
• FDA Determined Cause: Other
• Action: Letters issued dated February 4, 2005. The letters are flagged 'URGENT MEDICAL DEVICE RECALL'. Distributors are instructed to notify their customers to the retail (practitioner) level. All customers are instructed to return product.
• Quantity in Commerce: 798 cartons distrib. by B&L, Rochester, NY
• Distribution: There are 134 eye care practitioners, 191 mass retailers, 19 distributors, 14 consumers, and 3 mail order businesses.
• 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.