BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3223754 · Received July 10, 2013

    Report

    Report Number
    2028159-2013-01345
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS ONE OF TWO COMPLAINTS REPORTED FOR THIS ISSUE. THIS IS ONE OF TWO COMPLAINTS FOR THE FIRST FINISH GOODS LOT FOR THIS ISSUE. THE ORDER WAS BUILT AND RELEASED PER SPECIFICATION. THERE HAVE BEEN NO ADDITIONAL COMPLAINTS REPORTED AGAINST THE SECOND FINISH GOODS LOT AND THE DHR (DEVICE HISTORY RECORD) SHOWS THE PRODUCT WAS RELEASED PER SPECIFICATIONS. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECT OF FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE IS UNKNOWN. WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. THE OPERATOR'S MANUAL PROVIDES THE FOLLOWING IN REGARD TO LOSS OF ASPIRATION/SUCTION ISSUE: INSUFFICIENT ASPIRATION, PROBABLE CAUSE: LOOSE BLUE LUER FITTINGS, DAMAGED O-RING (ULTRAFLOW I/A HANDPIECE ONLY), CLOGGED TIP, KINKED OR DAMAGED TUBING, CRACKED BLUE FITTING. CORRECTIVE ACTION: RECONNECT SECURELY, INSPECT O-RING AND REPLACE, AS NECESSARY, FLUSH TIP WITH STERILE WATER OR BSS STERILE IRRIGATION SOLUTION. RETEST. REPLACE TIP. RETEST. CHECK TUBING AND/OR REPLACE FMS. CHECK FITTING AND/OR REPLACE FMS. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT EXPERIENCED A PERFORATED POSTERIOR CAPSULE DURING A CATARACT WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER IOL WAS IMPLEMENTED. THE SURGEON STARTED THE PROCEDURE IN QUADRANT MODE BUT THE VACUUM SYSTEM DID NOT WORK. SHE INCREASED THE VACUUM FROM 300 TO 400 BUT IT DID NOT WORK AND THE VACUUM COUNTER ON THE DISPLAY DID NOT INCREASE. THE TIP AND SLEEVE WERE CHANGED AND THE SYSTEM WAS TESTED, BUT THE PROBLEM CONTINUED. THE SURGEON INSERTED THE TIP INTO THE NUCLEUS BUT SHE COULD NOT "DRIVE THE NUCLEUS UP." THE "VOICE OF PHACO" WAS COMING BUT SHE WAS UNABLE TO ASPIRATE WITH PHACO. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317873 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OZIL TORSIONAL PHACO HANDPIECE| PACK INTREPID PLUS BASIC