Venus Eye Sphere 16 mm (Sterile)
FDA Recall Z-0530-03 · Posted 2003-02-05
Recalling FirmGulden Ophthalmics
Recall StatusTerminated
Product CodeHQX
Date Initiated2002-11-29
Date Terminated2004-02-06
Reason for Recall
lack of sterility assurance
Firm Action
The recalling firm issued letters to the accounts requesting the return of the devices.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.