Recall Z-1252-2016
Innovative Ophthalmic Products, Inc · initiated February 22, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
Codes / lots: GS2014 GL2014 GL2015 GS2015
Reason for recall
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.
FDA-determined cause: Labeling False and Misleading
Action taken
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." For further questions please call (202) 857-6464
Details
- Recall number
- Z-1252-2016
- Initiated
- February 22, 2016
- Terminated
- September 16, 2016
- Product code
- KYF – Implant, Eye Valve
- Quantity
- 278 units
- Distribution
- Nationwide Distribution
- Recalling firm
- Innovative Ophthalmic Products, Inc, Costa Mesa, CA