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Terminated

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

FDA Recall Z-1252-2016 · Posted None

Recalling FirmInnovative Ophthalmic Products, Inc
Recall StatusTerminated
Product CodeKYF
Date Initiated2016-02-22
Date Terminated2016-09-16
Product Quantity278 units

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.

Firm Action

Innovative Ophthalmic Products, Inc ( IOP ) sent an Customer Notification letter dated February 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken. The letter informs the customers that IOP is recalling because the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement. Specifically, the new IFU caution statement is "Caution should be taken with supra-Tenon implantation of this device as erosion of the conjunctiva is known to result from the raised edge of the oval pressure ridge." For further questions please call (202) 857-6464

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062252MOLTENO3Iop, Inc. · 2006-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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