Class 2 Device Recall Bausch & Lomb, Renu Fresh

• Date Initiated by Firm: December 22, 2010
• Date Posted: February 02, 2011
• Recall Status: Terminated on September 04, 2012
• Recall Number: Z-1025-2011
• Recall Event ID: 57555
• Product Classification: Accessories, solution, ultrasonic cleaners for lenses - Product Code LYL
• Product: Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.
• Code Information: Lot number: GH0066
• Recalling Firm/ Manufacturer: Bausch & Lomb Inc; 1400 North Goodman Street; Rochester NY 14609-3547
• For Additional Information Contact: Michael Santalucia; 585-338-6000
• Manufacturer Reason for Recall: There is a potential for some packages to not meet sterility requirements.
• FDA Determined Cause: Other
• Action: On December 8, 2010, Target was visited by FDA/PHI-DO and was informed on the violation. The Target customers that received lot GH0078 were requested to return all affected product directly to the Bausch & Lomb Greenville, SC Distribution Center. Bausch and Lomb sent an Urgent Voluntary Medical Device Recall to all first consignees who were shipped the affected lot GH0066 of Renu Fresh Multipurpose Solution on/about December 22, 2010. Since Target customers had already been notified previously regarding lot GH0078, this lot number was not included in the subsequent recall notification. All consignees were requested to review their inventory, and return any of the affected product to Stericycle Pharmaceutical Services, 2670 Executive Drive, Indianapolis, IN 46241. Stericycle is conducting this recall under the control of Bausch & Lomb. For questions abut the recall process contact Stericycle, Inc. at 1-888-345-8316. For questions regarding this recall call 1-800-828-6974.
• Quantity in Commerce: 146,496/ 2 oz Bottles
• Distribution: Worldwide Distribution - USA including AL, CA, CT, FL, GA, HI, IA, IN, LA, MA, MI, NE, NJ, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WI and the countries Taiwan and Brazil
• 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.