Ophthalmic Slit Knives Recalled for Sterility Assurance Issue
Tecfen Medical is recalling 47 ophthalmic slit knives (model QKN2808) due to inability to assure sterility. The products were distributed worldwide including the US, and are used in eye surgery.
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: This is a Class II FDA medical device recall for a sterility assurance issue. No illnesses, injuries, or deaths have been reported. The hazard is theoretical—risk of infection from non-sterile ophthalmic surgical instruments without reported injury—which per the rubric qualifies as a High (3) severity.
Plain-English summary
Tecfen Medical is recalling approximately 47 ophthalmic slit knife instruments (2.8mm Slit Knife, Angled, model QKN2808) distributed worldwide. US distribution included Connecticut and Minnesota. International distribution included Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, United Arab Emirates, Qatar, Bangladesh, and Israel.
These are sterile surgical instruments intended for precise eye surgery incisions. The recall is due to inability to assure sterility of the affected lot (manufactured November 25, 2024; lot number ZGY24041104-01; expiration November 24, 2027). Non-sterile instruments used in eye surgery pose a risk of infection.
Healthcare providers and patients should not use the affected instruments. Tecfen Medical is the recalling firm and should be contacted for instructions regarding replacement, return, or destruction of the recalled product.
The recalled product
- Product
- Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
- Manufacturer
- Tecfen Medical
- Hazard
- sterility-failure
- infection-risk
Distribution
Distributed nationwide across the United States.
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