Innovative Ophthalmic Products, Inc: Medical Device Recall in 2016 - (Recall #: Z-1252-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 22, 2016

Date Posted: April 6, 2016

Recall Number: Z-1252-2016

Event ID: 73386

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.

Status: Terminated

Product Quantity: 278 units

Code Information:

GS2014 GL2014 GL2015 GS2015

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated