BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 724907 · Received June 9, 2006

    Report

    Report Number
    1119421-2006-00156
    Event Type
    Injury
    Date Received
    June 9, 2006
    Report Date
    May 10, 2006
    Manufacturer
    ALCON LABORATORIES, INC. /HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT

    Narratives

    Additional Manufacturer Narrative · 1

    H.3., 6.: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN REC'D FOR EVAL. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO SIMILAR COMPLAINTS REC'D FOR THIS LOT NUMBER. THE MFR'S INTERNAL REFERENCE NUMBER IS: ID061753. THIS REPORT WAS MAILED TO THE FDA ON: 06/09/2006.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED "MULTIPLE" CASES OF TASS FOLLOWING CATARACT PROCEDURES. PER THE REPORTER, THE CASES HAVE OCCURRED SPORADICALLY, IN NO PARTICULAR ORDER, AND WITH MULTIPLE SURGEONS. IN THIS CASE THE PT RECOVERED WITH THE USE OF TOPICAL STEROIDS. THE FACILITY IS INVESTIGATING MULTIPLE POTENTIAL CAUSES, INCLUDING CLEANING AND STERILIZATION PROCEDURES, ENVIRONMENTAL FACTORS, INSTRUMENTS AND PRODUCTS USED DURING CATARACT PROCEDURES. THE REPORTER STATES THEY PERFORM AN AVERAGE OF 40 SURGERIES PER DAY, CYCLE TWO INSTRUMENT TRAYS PER ROOM, HAVE RE-USEABLE CANNULAS, AND SOME OF THE OPERATING ROOM PERSONNEL ARE RECENTLY HIRED. EPINEPHRINE IS ADDED TO THE IRRIGATING SOLUTIONS AND PTS RECEIVE INTRACAMERAL VANCOMYCIN. A LISTING OF PRODUCTS AND LOT NUMBERS IN STOCK AT THE FACILITY WAS PROVIDED BY THE REPORTER. WITH THE EXCEPTION OF THE IOL LOT/SERIAL NUMBERS, THE FACILITY IS NOT ABLE TO IDENTIFY IF ANY OF THE PRODUCT LOTS IN THE LISTING THEY PROVIDED WERE SPECIFICALLY USED ON PTS WHO DEVELOPED TASS. A SITE VISIT BY A NURSE CONSULTANT WAS REQUESTED TO ASSIST THE FACILITY WITH THEIR ON-GOING INVESTIGATION. THE VISIT TOOK PLACE ON 05/10/2006. THE NURSE CONSULTANT REPORTED THE FACILITY HAD IDENTIFIED A POSSIBLE ASSOCIATION BETWEEN TASS AND THE INTRAOCULAR LENSES. THE NURSE CONSULTANT IDENTIFIED THE FOLLOWING ITEMS FOR FACILITY CONSIDERATION TO HELP PREVENT FUTURE CASES OF TASS: 1. USE OF COMPOUNDING CENTER RATHER THAN A NURSE TO COMPOUND MEDICATION; 2. USE AN ETOH RINSE AFTER DECONTAMINATION PHASE PRIOR TO STERILIZATION; 3. USE DISPOSABLE CANNULAS; 4. PRIOR TO USE, EXAMINE I&A HAND PIECE AND REUSABLE CANNULAS AND INJECTORS UNDER A MICROSCOPE FOR ANY SIGNS OF DEBRIS OR RESIDUALS; 5. SPEND ADDITIONAL TIME AT THE END OF THE CASE FLUSHING THE EYE WITH BALANCED SALT SOLUTION; AND, 6. USE ENZYMATIC CLEANER THAT HAS NOT EXPIRED. 1119421-2006-00116, -00152, -00153, -00154, -00155, -00156, -00157, -00158, -00159, -00160, -00161, -00162, -00163, -01164, -01165, -01166, -01167, -01168, -01169, -01170, -01171, -01172, -01173, -01174.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. /HUNTINGTON SA60AT 947567

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention