FDA-Device2016-04-06Class II
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
Innovative Ophthalmic Products, Inc
Hazard
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.
Sold states
Nationwide Distribution
Affected count
278 units
Manufactured in
3184 Airway Ave Ste B, N/A, Costa Mesa, CA, United States
Products
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1252-2016Don't want to check this manually?
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