Tecfen Medical 2.0mm Crescent Knife Ophthalmic Device Recall
Tecfen Medical is recalling 2.0mm Crescent Knife ophthalmic surgical instruments (Model QKN1010, Lot ZGY24071501-03) due to sterility assurance concerns. The affected devices were distributed in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II surgical instrument with a sterility assurance issue, which poses a risk of contamination and potential harm in a high-risk surgical setting. No illnesses or injuries have been reported, keeping the score at 3 rather than 4.
Plain-English summary
Tecfen Medical is recalling the 2.0mm Crescent Knife Angled Bevel Up (Model QKN1010, Lot Number ZGY24071501-03) distributed worldwide due to sterility assurance concerns. This is a manually operated ophthalmic surgical knife used to create smooth, curved incisions for corneal transplant procedures, small incision cataract surgery, phacoemulsification, and trabeculectomy procedures.
The affected lot was manufactured on November 22, 2024, with an expiration date of November 21, 2027. The 42-unit lot (UDI: 00817618021330) was distributed in the United States in Connecticut and Minnesota, as well as internationally to the Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, Brazil, and Israel.
Healthcare providers and hospitals with this product should contact Tecfen Medical regarding the sterility assurance issue. No illnesses or injuries have been reported to date in connection with this recall. Users with questions should refer to the FDA database reference Z-1954-2025 for additional information.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent kn
- Manufacturer
- Tecfen Medical
- Affected units
- 42
Distribution
Part of a larger recall action
This product is one of 7 recalled by Tecfen Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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