Recall Z-1252-2016 ยท KYF Implant, Eye Valve
Innovative Ophthalmic Products, Inc
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
| Date | Feb 22, 2016 |
| Status | Terminated |
| Reason | Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to minimize off-label use. |
| Root cause | Labeling False and Misleading |
| Action | Innovative Ophthalmic Products, Inc ( IOP ) sent an Customer Notification letter dated February 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken. The letter informs the customers that IOP is recalling because the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement. Specifically, the new IFU caution statement is "Caution should be taken with supra-Tenon implantation of this device as erosion of the conjunctiva is known to result from the raised edge of the oval pressure ridge |
| Quantity | 278 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062252 | MOLTENO3 Iop, Inc., Sep 27, 2006 |