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U.S. Department of Health and Human Services

Class 2 Device Recall Molteno3 Glaucoma Implants GSeries

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 Class 2 Device Recall Molteno3 Glaucoma Implants GSeriessee related information
Date Initiated by FirmFebruary 22, 2016
Create DateMarch 25, 2016
Recall Status1 Terminated 3 on September 16, 2016
Recall NumberZ-1252-2016
Recall Event ID 73386
510(K)NumberK062252 
Product Classification Implant, eye valve - Product Code KYF
ProductMolteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
Code Information GS2014 GL2014 GL2015 GS2015 
Recalling Firm/
Manufacturer		 Innovative Ophthalmic Products, Inc
3184 Airway Ave Ste B
Costa Mesa CA 92626-4619
For Additional Information ContactNaomi Halpern
202-857-6464
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionInnovative 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 Commerce278 units
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KYF
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