InjuryFLF
ABTOX PLAZLYTE STERILIZER
Received Jan 27, 1998 · Event occurred Jan 8, 1998
Report MW1012892 · MDR key 146324
Device
Generic name
Instrument Sterilizer
Manufacturer
Abtox Inc.Model number
PLAZLYTE LOWCatalog number
TEMPERATURE GAS
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Corneal Decompensation
Narrative
Description of Event or Problem
FOLLOWING SURGERY DURING TIME PERIOD OF 1/8/98-1/14/98, 6 PTS SUSTAINED POSTOPERATIVE CORNEA ENDOTHELIAL CELL DECOMPENSATION. ONE COMMON ELEMENT APPEARS TO BE ABTOX PLAZLYTE STERILIZATION PROCESS. HOWEVER, MORE INDEPTH INVESTIGATION UNDERWAY TO VERIFY CAUSE.