BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2250738 · Received September 12, 2011

    Report

    Report Number
    2028159-2011-01077
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE SENT FOR EVAL. THE FOLLOWING REPRESENTS DEFICIENCIES FOUND BY THE (B)(4) DURING A SITE VISIT: INADEQUATE MANUAL CLEANING OF INSTRUMENTATION. INADEQUATE AMOUNT OF WATER USED TO FLUSH THE PHACO AND I&A HANDPIECES. USE OF TAP WATER IN THE INSTRUMENT CLEANING PROCESS. POSSIBLE BACTERIAL GROWTH ON INSTRUMENTS LEFT SITTING ON THE COUNTER OVERNIGHT WITHOUT TERMINAL STERILIZATION. FAILURE TO DRAIN THE STATLM STERILIZER DAILY. STRESSING THE SYSTEM. USE OF TETRAVISC IMMEDIATELY PRIOR TO DRAPING. USE OF A PAPER TOWEL TO SET INSTRUMENTS ON THE BACK TABLE AND/OR USE A CLOTH TO PLACE INSTRUMENTS ON FOLLOWING USE. TOUCHING THE TIPS OF INSTRUMENTS OF LENS INSERTION CARTRIDGE OR THE IMPLANT ITSELF WITH A GLOVED FINGER. THE FACILITY USED TAP WATER IN THEIR INSTRUMENT PROCESSING. IN A STUDY CONDUCTED BY THE (B)(4) IT WAS DISCOVERED THAT RESIDUE COMPOSED OF TRACE AMOUNTS OF COPPER AND ZINC IONS WERE FOUND ON STERILIZED INSTRUMENTS. THE CHROME COVERING THE CANNULAS MAY HAVE WORN AWAY OR THE SOLDER JOINTS DECOMPOSED, RESULTING IN LEACHING AND OXIDATION OF THE UNDERLYING EXPOSED BRASS METAL. AFTER STERILIZATION, COPPER AND ZINC DEPOSITS REMAINED IN THE LUMENS OF CANNULAS AND FOUND TO HAVE BEEN FLUSHED INTO THE EYE DURING SURGERY. POOR PLUMBING CAN CONTAMINATE THE AUTOCLAVE WATER, WHICH CAN IN TURN CONTAMINATE HANDPIECES OR OTHER INSTRUMENTS THAT ARE PUT IN IT. THESE FINDINGS CONTINUE TO VALIDATE THE NEED TO FOLLOW THE RECOMMENDATIONS DETAILED IN THE DFUS, AORN RECOMMENDED PRACTICES, AND THE "RECOMMENDED PRACTICES FOR CLEANING AND STERILIZING INTRAOCULAR SURGICAL INSTRUMENTS" FROM ASCRS AND ASORN. THE ROOT CAUSE IS UNK. THE COPY OF THE DIRECTIONS FOR USE FOR THE PHACO HANDPIECE AND A COPY OF THE "RECOMMENDED PRACTICES FOR CLEANING AND STERILIZING INTRAOCULAR SURGICAL INSTRUMENTS" FROM ASCRS AND ASORN WERE SENT TO THE CUSTOMER. THE CONSULTANTS INSTRUCTED THE FACILITY ON PROPER INSTRUMENT HANDLING AND CLEANING PRACTICES, AND URGED THEM TO FOLLOW THE "RECOMMENDED PRACTICES FOR CLEANING AND STERILIZING INTRAOCULAR SURGICAL INSTRUMENTS" FROM ASCRS AND ASORN. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A PT WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT PRESENTED, DURING THE ONE DAY POSTOPERATIVE VISIT, WITH INFLAMMATION. NO CULTURES WERE TAKEN. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BALANCED SALT SOLUTION| BETADINE| VIGAMOX| VANCOMYCIN| OZIL TORSIONAL PHACO HANDPIECE| DUOVISC| IOL