BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 2051219 · Received April 6, 2011

    Report

    Report Number
    2028159-2011-00356
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 27, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE POWER AND COMMUNICATIONS CABLES. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLE WAS RETURNED. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 04/06/2011. (B)(4).

    Description of Event or Problem · 1

    DURING A COMPLICATED VITREO-RETINAL SURGERY WITH IOL REPLACEMENT, A SYSTEM MESSAGE OCCURRED DURING THE VITRECTOMY (VITREOUS/AIR EXCHANGE). MAJOR HYPOTONY OCCURRED THAT REQUIRED THE PROCEDURE TO BE COMPLETED BY MANUALLY FILLING THE EYE WITH AIR WITH A SYRINGE. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER MORE INFORMATION REGARDING THE PATIENT'S OUTCOME, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention