InjuryHNY

CYSTOTOME

Received Mar 20, 2008 · Event occurred Sep 11, 2007

Report MW5005968 · MDR key 1017532

Device

Generic name

Cystotome

Manufacturer

Bausch & Lomb

Model number

Catalog number

E-141-2S

Lot number

Product problems

Flaked
Device, removal of (non-implant)

Patient

Foreign body, removal of
Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

BLACK PARTICULATE FLAKING FROM BAUSCH & LOMB OPHTHALMIC INSTRUMENTS: IRRIGATION CANNULA, STRAIGHT CANNULA, POLISHER, & CYSTOTOME. PARTICULATE REMOVED FROM SURGICAL SITE VIA MICROSCOPIC VISUALIZATION. RESPONSE FROM BAUSCH & LOMB INDICATED THAT SOME LOTS OF INSTRUMENT HUBS WERE MANUFACTURED WITH A THINNER THAN USUAL BRASS COATING ON THE NICKEL HUB. INSTRUMENT HUBS DETERIORATED WITH PROPER STERILIZATION TECHNIQUE. DATES OF USE #1: 3 1/2 YEARS; #2: 3 1/2 YEARS. DIAGNOSIS OR REASON FOR USE #1: INSTRUMENTATION, #2: INSTRUMENTATION. EVENT ABATED AFTER USE STOPPED: #1: YES; #2: YES.