PLAZLYTE STERILIZER
Received Apr 13, 1998 · Event occurred Apr 13, 1998
Report MW1013482 · MDR key 162019
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
NO INFO
- Complaint, Ill-Defined
Narrative
Description of Event or Problem
ACCORDING TO THE RPTR, SHE REC'D A CALL FROM THE CLINICAL EDUCATOR AT ABTOX. THE RPTR WAS INFORMED TO STOP PROCESSING INSTRUMENTS USED FOR EYE SURGICAL PROCEDURES IN THE PLAZLYTE STERILIZER. REPORTEDLY, A HOSP HAD 6-8 PTS DEVELOP COMPLICATIONS FOLLOWING EYE SURGERY. THE COMPLICATIONS MIGHT BE RELATED TO THE STERILIZATION PROCESS. SINCE THE RPTR'S FACILITY HAS EXPERIENCED NO PROBLEMS OF THIS NATURE, SHE WISHES TO CONTINUE USING THIS STERILIZATION METHOD. SHE FEELS THE KEY TO AVOIDING COMPLICATIONS IS TO STRICTLY ADHERE TO THE MFR'S RECOMMENDED PRACTICES/PROCEDURES. SHE IS SEEKING FDA'S GUIDANCE ON USING THIS METHOD OF STERILIZATION FOR INSTRUMENTS USED DURING EYE SURGIAL PROCEDURES.