Molteno3 Glaucoma Implants Recalled for Updated Instructions
Innovative Ophthalmic Products is recalling Molteno3 Glaucoma Implants because the package insert was updated to add a caution statement to minimize off-label use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is driven by an update to the Instructions for Use to minimize off-label use, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Innovative Ophthalmic Products (IOP) is recalling the Molteno3 G-Series Glaucoma Implants. The specific units affected are the GS-Single Plate 175mm2 (IOP reorder#: M3-175) and GL-Single Plate 230mm2 (IOP reorder#: M3-230). The recall involves 278 units with lot codes GS2014, GL2014, GL2015, and GS2015, which were distributed nationwide.
The reason for the recall is that the package insert and Instructions for Use (IFU) for the device have been updated. The update adds a caution statement intended to minimize off-label use of the implant.
Healthcare providers and patients should review the updated Instructions for Use to ensure the device is used appropriately. No specific instructions for consumer action are provided in the source text beyond the update to the documentation.
The recalled product
- Product
- 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
- Category
- Medical Device — Ophthalmic
- Affected units
- 278
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GS2014 GL2014 GL2015 GS2015
Distribution
Distributed nationwide across the United States.
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