Class 2 Device Recall Venus Eye Sphere 20 mm (sterile)

• Date Initiated by Firm: November 29, 2002
• Date Posted: February 05, 2003
• Recall Status: Terminated on February 06, 2004
• Recall Number: Z-0532-03
• Recall Event ID: 25123
• 510(K)Number: K972661
• Product Classification: Implant, Orbital, Extra-Ocular - Product Code HQX
• Product: Venus Eye Sphere 20 mm (Sterile)
• Code Information: model number 14155. lot number 8404
• Recalling Firm/ Manufacturer: Gulden Ophthalmics; 225 Cadwalader Ave; Elkins Park PA 19027-2020
• For Additional Information Contact: Thomas D. Cockley; 215-884-8105
• Manufacturer Reason for Recall: lack of sterility assurance
• FDA Determined Cause: Other
• Action: The recalling firm issued letters to the accounts requesting the return of the devices.
• Distribution: Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
• 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.

• 510(K) Database: 510(K)s with Product Code = HQX