DEX Ophthalmic Tissue Forceps require instructions-for-use correction
Katalyst Surgical is correcting the instructions for use (IFU) for DEX Ophthalmic Tissue Forceps (Model DVF4019-27) and related scissors due to a field safety issue.
What this means for you
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: This is an FDA Class II recall involving a corrective action to labeling/instructions for use. The source text does not report any injuries, illnesses, or adverse events. The issue is limited to documentation correction, which is a moderate-level concern.
Plain-English summary
Katalyst Surgical, LLC is issuing a field safety corrective action for the DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps (Model/Catalog Number DVF4019-27). The recall involves a correction to the instructions for use (IFU) for this device and related DEX scissors products.
The device has been distributed worldwide, including to the US and internationally to Peru, Argentina, South Korea, Japan, and France. A total of 150 units are affected across multiple lot numbers.
Customers who have received these devices should consult the corrected instructions for use provided by Katalyst Surgical, LLC. For specific lot numbers or additional information, contact the manufacturer at the contact information provided by the FDA.
The recalled product
- Product
- DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
- Manufacturer
- Katalyst Surgical, LLC
- Hazard
- mis-labeling
Distribution
Distributed nationwide across the United States.
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