FDA Device

BD K-3000 Microkeratome Blade REF 378607

Hazard

Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.

What You Should Do

Remedy

BD Ophthalmic notified customers by telephone and email on 1/ 24/03. Users are requested to destroy blades and Certify destruction by returning reply form.

Products

BD K-3000 Microkeratome Blade REF 378607
Brand
BD Opthalmic Systems
UPC
Manufacturing Lot Numbers: 959, 962, 964, 965, and 966

Units Affected

1539 Blades