InjuryFLF
PLAZLYTE STERILIZER
Received Feb 13, 1998 · Event occurred Jan 8, 1998
Report 2939576-1998-00002 · MDR key 148936
Device
Generic name
Gas Sterilizer
Manufacturer
Abtox, Inc.Model number
ABT 1.0Catalog number
PL006-01-02
Lot number
NA
Patient
74 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.