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Recall Observatory FDA recall evidence

Device product

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

Z-1252-2016

February 22, 2016

Class II

Product summary

Firm
Innovative Ophthalmic Products, Inc
Event
Event 73386
Status
Terminated
Classification
Class II
Quantity
278 units
Official record key
device-enforcement:Z-1252-2016

Official wording

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.

Code information: GS2014 GL2014 GL2015 GS2015

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.