inforMED
InjuryFLF

PLAZLYTE STERILIZER

Received Feb 13, 1998

Report 2939576-1998-00006 · MDR key 148928

Device

Generic name

Gas Sterilizer

Manufacturer

Abtox Inc

Model number

ABT 1.0

Catalog number

PL006-01-02

Lot number

NA

Patient

66 YR

Narrative

Description of Event or Problem

PT DEVELOPED POSTOP CORNEA ENDOTHELIAL CELL DECOMPENSATION. SURGICAL INSTRUMENTS WERE STERILIZED IN THE PLAZLYTE PROCESS. CAUSE IS UNK. SIMILAR SURGERIES WERE PERFORMED WITH INSTRUMENTS STERILIZED IN THE SAME PROCESS WITHOUT ADVERSE EVENT. PUBLISHED LITERATURE LISTS CAUSES OF CORNEAL DECOMPENSATION TO INCLUDE SURGICAL TECHNIQUES, RESIDUAL DETERGENT/GLUTERALDEHYDE, ETC.