Z-1252-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2016
- Initiation Date
- February 22, 2016
- Termination Date
- September 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 278 units
Product Description
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
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.
Distribution Pattern
Nationwide Distribution
Code Information
GS2014 GL2014 GL2015 GS2015