HMYClass I

Keratome, Battery-powered

Ophthalmic · 21 CFR 886.4370

MDR events51All time

Recalls2All time

Registered firms19Currently listed

510(k) clearances12All time

Recent MDR events

51 adverse event reports on file

Event type breakdown

Injury32

Malfunction13

Other6

Most-reported manufacturers

Moria Sa21 Bd Ophthalmic Systems13 Unspecified7 Moria S.a.3 Moria2 Moria, S.a., C.e.2 Moria, Sa2 Moria, S A1

Recalls

2 recall events for this product code

Becton Dickinson and Company
TerminatedOct 23, 2007
BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)
Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea
Z-0066-2008 · View FDA record ↗
BD Opthalmic Systems
TerminatedMar 12, 2003
BD K-3000 Microkeratome Blade
Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.
Z-0634-03 · View FDA record ↗

Registered firms

19 firms currently registered for this product code

510(k) clearances

12 clearances for this product code