BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 1051665 · Received May 21, 2008

    Report

    Report Number
    2028159-2008-00179
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REQUEST A SERVICE REQUEST TO CHECK THE SYSTEM NOR DID THEY RETURN SAMPLES FOR EVAL. THE POSTOPERATIVE ENDOPHTHALMITIS, A GUIDE TO DIAGNOSIS & TREATMENT WAS SENT TO THE SURGEON. THE ROOT CAUSE OF THE PT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION. ENDOPHTHALMITIS IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. A REVIEW OF THE COMPLAINTS AND SERVICE DATA FILES FOR THE SYSTEMS INDICATES THAT THERE HAVE BEEN NO ADD'L COMPLAINTS OR SERVICE REQUESTS RELATED TO THE REPORTED EVENT. A TREND REVIEW OF THE COMPLAINT INDICATES THAT THERE HAS BEEN NO RECENT ADVERSE TRENDING OBSERVED IN THE LAST 36 MONTHS. THE REPORTER DID NOT IDENTIFY TASS, BUT ALCON HAS CLASSIFIED THIS TYPE OF EVENT AS POTENTIALLY TASS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CASE OF ENDOPHTHALMITIS. THE SERIAL NUMBER OF THE SYSTEM WAS NOT SPECIFIED, BUT UPON REVIEW OF THE SERVICE RECORDS, IT INDICATES THAT THERE ARE TWO SYSTEMS ON SITE. THE SURGEON INITIALLY STATED THE PROGNOSIS OF THE PT WAS "NOT GOOD". PER THE QUESTIONNAIRE RECEIVED, A VITRECTOMY PROCEDURE WAS PERFORMED. THE PT REPORTED PAIN IN THE FOLLOWING DAY. THE SURGEON THEN INJECTED ANTIBIOTICS INTO THE PT. THE OUTCOME OF THE PT WAS NOTED AS POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VANCOMYCIN| INTRAVITREAL INJECTION OF ANTIBIOTICS| CEFAZOLIN