Innovative Ophthalmic Products, Inc recalls Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#…

Recall date

February 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1252-2016

FDA classification

Class II

Brand / firm

Innovative Ophthalmic Products, Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)