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U.S. Department of Health and Human Services

Class 2 Device Recall Venus Eye Sphere 22 mm (sterile)

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  Class 2 Device Recall Venus Eye Sphere 22 mm (sterile) see related information
Date Initiated by Firm November 29, 2002
Date Posted February 05, 2003
Recall Status1 Terminated 3 on February 06, 2004
Recall Number Z-0533-03
Recall Event ID 25123
510(K)Number K972661  
Product Classification Implant, Orbital, Extra-Ocular - Product Code HQX
Product Venus Eye Sphere 22 mm (Sterile)
Code Information model number 14156. lot number 8447
Recalling Firm/
Gulden Ophthalmics
225 Cadwalader Ave
Elkins Park PA 19027-2020
For Additional Information Contact Thomas D. Cockley
Manufacturer Reason
for Recall
lack of sterility assurance
FDA Determined
Cause 2
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 and Original Applicant = GULDEN OPHTHALMICS