BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 853353 · Received May 17, 2007

    Report

    Report Number
    1644019-2007-00013
    Event Type
    Injury
    Date Received
    May 17, 2007
    Report Date
    April 16, 2007
    Manufacturer
    ALCON - HOUSTON
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALCON PRODUCT WAS IDENTIFIED AS THE CAUSE OF TASS PER THE SITE VISIT, AND THE VISIT REVEALED THAT THERE WERE MANY RECOMMENDED OPHTHALMIC PRACTICES THAT WERE NOT BEING FOLLOWED. THE AUDITOR CITED THE DISCREPANCIES AND MADE RECOMMENDATIONS TO COMPLY WITH RECOMMENDED PRACTICES. THE FACILITY STATED, THEY HAVE MADE MANY CHANGES IN THEIR CATARACT PROCEDURE PRACTICE, AFTER THE SITE VISIT AUDIT AND RECOMMENDATIONS WERE GIVEN TO THEM. THIS IS INCLUDED IN THE ACTION ITEM OF THE SITE VISIT. THEY HAVE PERFORMED SURGERY SEVERAL TIMES AND HAVE NOT HAD ANY CASES OF TASS SINCE THE SITE VISIT AND THE IMPLEMENTATION OF NEW PRACTICES.

    Description of Event or Problem · 1

    THE FACILITY HAS BEEN EXPERIENCING TASS, AND THEY DO NOT KNOW WHAT COULD BE SOURCE. NO PATIENT INFORMATION WAS PROVIDED, AND NO ADDITIONAL INFORMATION IS EXPECTED. A TASS SITE VISIT WAS PERFORMED IN 2007. THE NURSE CONSULTANT REVIEWED THEIR CATARACT PRACTICE PROCEDURE AND HAD THE FOLLOWING RECOMMENDATIONS. FOLLOW RECOMMENDED PRACTICES FOR CLEANING AND STERILIZING INTRAOCULAR SURGICAL INSTRUMENTS. REFRAIN FROM USING ENZYMATIC CLEANER. USE STERILE WATER FOR FINAL INSTRUMENT PROCESSING. CLEAN INSTRUMENTS AS SOON AS CASE IS COMPLETED. USE PRESERVATIVE FREE MEDICATIONS ONLY AT THE END OF THE CASE. USE PRESERVATIVE FREE MEDICATIONS INSIDE THE EYE. CONTINUE FLUSHING EYE AFTER BETADINE PLACED IN CUL DE SAC AT BEGINNING OF THE PROCEDURE. DISCONTINUE RE-USE OF SINGLE USE ITEMS. DECREASE NUMBER OF ITEMS THAT IOL COMES IN CONTACT WITH A CORRECT USAGE OF FORCEPS TO LOAD IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK NONE HQE ALCON - HOUSTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR