Tecfen Medical recalls 2.0mm Crescent Knife Angled Bevel Up (QKN1010) due to potential sterility issues affecting eye surgery safety. This ophthalmic knife is used in corneal transplants and cataract procedures.
Sterility assurance for Ophthalmic knives.
Tecfen Medical is recalling its 2.0mm Crescent Knife Angled Bevel Up (model QKN1010) because it may not maintain sterility during eye surgery. This poses a risk of infection or complications if used without proper sterile packaging.
The knife is designed to be sterile and packaged individually in Tyhvek 1059B, but the recall indicates potential issues with sterility assurance. If the knife is not properly sterile, it could lead to infections or complications during eye surgery.
Ophthalmic surgeons and medical professionals who use this knife for eye procedures like corneal transplants and cataract surgery. Patients undergoing these procedures are at risk if the knife is not sterile.
Check for the model number QKN1010 on the knife. The product was manufactured on November 22, 2024, and expires November 21, 2027. It is used in eye surgery procedures like corneal transplants.
Ensure the knife is in its original sterile Tyhvek 1059B packaging before use.
The recall indicates potential sterility issues, so it is not recommended for use until the recall is addressed.
Look for the model number QKN1010 on the knife, which was manufactured on November 22, 2024, and expires November 21, 2027.
The recall does not specify a remedy, so contact Tecfen Medical directly for guidance.
We’ve drafted a message you can send Tecfen Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1954-2025 — Tecfen Medical Tecfen Medical Hello, I own a Tecfen Medical that is covered by recall Z-1954-2025 from Tecfen Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
