Recall Z-2802-2011 ยท HQL Intraocular Lens
Hoya Surgical Optics, Inc.
iSert Intraocular Lens (Model PC-60AD)
| Date | Jul 14, 2011 (initiated Jun 17, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval. |
| Root cause | PMA |
| Action | Hoya Surgical Optics Inc. sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated June 22, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken. The letter instructs customers to quarantine affected product and return to HSO at their earliest convenience. Shipping instructions are included in the letter. Customers are to complete an Effectiveness Check Questionnaire and fax it to 1-909-680-3986. Questions regarding the recall process are directed to Hoya Customer Service at 1-866-750-5870 or e-mail at customercare@hoyasurgopt.com. |
| Quantity | 33,743 units total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.