Reported Apr 6, 2016 · Terminated
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP…
Innovative Ophthalmic Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Innovative Ophthalmic Products, Inc · 3184 Airway Ave Ste B · Costa Mesa, CA · 92626-4619
Is this the product you have?
- Molteno3 Glaucoma Implants G-SeriesGS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
- Lot codes and dates
- GS2014 GL2014 GL2015 GS2015
- Amount recalled
- 278 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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