Recall Z-1710-2009 ยท HKS Prism, Gonioscopic
Volk Optical Inc
G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
| Date | Jul 21, 2009 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.' |
| Root cause | Process design |
| Action | Volk Optical Inc. contacted their customers and notified them of affected device via E-mail, letter, and Fax transmittals starting June 30, 2008. The recall notification(s) describes the engraving error and instructs the users on steps to replace the affected product. For further questions, contact Volk Optical Inc. at 1-800-345-8655 extension 443 . |
| Quantity | 15 |
| Distribution | Worldwide Distribution -- Great Britain, China and the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.