BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1772321 · Received July 23, 2010

    Report

    Report Number
    2028159-2010-01304
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    June 24, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNKNOWN AT THIS TIME. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "ENDOPHTHALMITIS" (ENDOPHTHALMITIS). PRODUCT PROBLEM(S): "NO DEVICE PROBLEM REPORTED" (NO KNOWN DEVICE PROBLEM). A USER FACILITY REPORTED THIRTEEN CASES OF ENDOPHTHALMITIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. FOUR PATIENTS WERE OPERATED ON (B)(6)2010 AND NINE WERE OPERATED ON (B)(6)2010. ON (B)(6)2010, TEN OF THE THIRTEEN CASES HAD SECONDARY SURGERIES. FOUR PATIENTS LOST THEIR VISION AND FOUR OTHERS ARE IN CRITICAL CONDITION TO LOSING THEIR VISION. THE REMAINING FIVE PATIENTS WERE IMPROVING. THERE ARE NO PATIENT IDENTIFIERS CURRENTLY AVAILABLE. A DIFFERENT SYSTEM, INTRAOCULAR LENS, VISCOELASTIC AND BSS WERE USED IN BOTH SURGERIES. BUT THE ONLY COMMON PRODUCT USED WAS THE BSS. THE FACILITY IS INVESTIGATING THE CAUSE OF THE INCIDENTS. THE DIRECTOR OF THE OPHTHALMOLOGY CLINIC CONFIRMED THAT THE ENDOPHTHALMITIS WAS CAUSED DUE TO A RESISTANT STRAIN OF PSEUDOMONAS IN THE SITE. THERE ARE TWO INCIDENTS BEING FILED FOR THIS FACILITY. IN EACH INCIDENT, THERE ARE FOUR MEDICAL DEVICES INVOLVED. FOUR INDIVIDUAL REPORTS ARE BEING FILED FOR EACH OF THE MEDICAL DEVICES INVOLVED. THIS REPORT IS FOR THE SYSTEM. THIS REPORT IS FOR THE THREE PATIENTS WITH NO SECONDARY SURGERIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BSS| UNSPECIFIED VISCOELASTIC| SERIES 20000 LEGACY