Events

Recall of Device Recall Molteno3 Glaucoma Implants GSeries

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Innovative Ophthalmic Products, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73386
  • Event Risk Class
    Class 2
  • Event Number
    Z-1252-2016
  • Event Initiated Date
    2016-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144004
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, eye valve - Product Code KYF
  • 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.
  • 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

Device

Device Recall Molteno3 Glaucoma Implants GSeries
  • Model / Serial
    GS2014 GL2014 GL2015 GS2015
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Molteno3 Glaucoma Implants G-Series: || GS-Single Plate 175mm2 (IOP reorder#: M3-175) || GL-Single Plate 230mm2 (IOP reorder#: M3-230)
  • Manufacturer
    Innovative Ophthalmic Products, Inc

Manufacturer

Innovative Ophthalmic Products, Inc
  • Manufacturer Address
    Innovative Ophthalmic Products, Inc, 3184 Airway Ave Ste B, Costa Mesa CA 92626-4619
  • Manufacturer Parent Company (2017)
    Innovative Ophthalmic Products Inc
  • Source
    USFDA