Recall Z-1252-2016— Innovative Ophthalmic Products, Inc
Class II · Terminated
Class II FDA medical device recall by Innovative Ophthalmic Products, Inc, initiated 2016-02-22, terminated 2016-09-16. It names one FDA 510(k) clearance: K062252. Product: Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230). 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..
- Recalling firm
- Innovative Ophthalmic Products, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-22
- Terminated
- 2016-09-16
- Firm location
- Costa Mesa, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.