BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 1772220 · Received July 22, 2010

    Report

    Report Number
    2028159-2010-01259
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 22, 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
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS 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): "POSTERIOR CAPSULE TEAR" (CAPSULAR BAG TEAR, POSTERIOR). PRODUCT PROBLEM(S): "NO DEVICE PROBLEM REPORTED" (NO KNOWN DEVICE PROBLEM). A CUSTOMER REPORTED THAT A POSTERIOR CAPSULAR RUPTURE OCCURRED DURING POLISHING ON CAPSULE VACUUM MODE. THE TIPS HAVE BEEN RESTERILIZED SEVERAL TIMES THOUGH THE CUSTOMER IS NOT SURE HOW MANY TIMES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention