Recall Z-0530-03 ยท HQX Implant, Orbital, Extra-Ocular
Gulden Ophthalmics
Venus Eye Sphere 16 mm (Sterile)
| Date | Feb 5, 2003 (initiated Nov 29, 2002) |
| Status | Terminated |
| Reason | lack of sterility assurance |
| Root 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972661 | EYE SPHERE, CONFORMERS Gulden Ophthalmics, Oct 3, 1997 |