Recall Z-1954-2025— Tecfen Medical
Class II · Ongoing
Class II FDA medical device recall by Tecfen Medical, initiated 2025-04-25. FDA's recall record names no specific 510(k) clearance for this event. 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 knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy. Component: No. Reason: Sterility assurance for Ophthalmic knives..
- Recalling firm
- Tecfen Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-25
- Firm location
- Santa Barbara, CA, United States
Product description
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 knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy. Component: No
Reason for recall
Sterility assurance for Ophthalmic knives.
Data sourced from openFDA. This site is unofficial and independent of the FDA.