Z-1252-2016Class II

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

Name: Z-1252-2016 Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2...
Creator: Innovative Ophthalmic Products, Inc
Published: 2016-02-22
License: https://open.fda.gov/license/

Innovative Ophthalmic Products, Inc / initiated 2016-02-22 / Terminated / root cause: labeling and UDI

FDA source

Innovative Ophthalmic Products, Inc began a recall of Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230) on 2016-02-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1252-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-22
Posted: 2016-03-25
Terminated: 2016-09-16
Recalling firm: Innovative Ophthalmic Products, Inc
Product: Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
Product code: KYF Implant, Eye Valve
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
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
Quantity in commerce: 278 units
Distribution: Nationwide Distribution
Product codes and lots: GS2014 GL2014 GL2015 GS2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1252-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1252-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25

Product code KYF

K062252Class IIMolteno3Iop, Inc. / cleared 2006-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)