BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 400VS

    MDR report key: 1672477 · Received April 30, 2010

    Report

    Report Number
    2028159-2010-00562
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 1, 2010
    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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE REFLUX WAS CHECKED IN THE VITRECTOMY AND EXTRUDE MODES WITH NO PROBLEMS OBSERVED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "THE PATIENT HAD A HOLE IN THE RETINA" (RETINA, TEAR(S) IN). PRODUCT PROBLEM(S): "SURGEON WAS UNABLE TO PERFORM REFLUX DURING SURGERY" (REFLUX WITH DEVICE). THE NURSE REPORTED THE SURGEON WAS UNABLE TO PERFORM REFLUX DURING SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE NURSE STATED THE EVENT OCCURRED TOWARDS THE END OF THE CASE. NO SYSTEM MESSAGES DISPLAYED. THE SURGEON WAS ABLE TO COMPLETE THE CASE. THE PATIENT HAD A HOLE IN THE RETINA. IT IS UNKNOWN WHEN THE RETINAL HOLE OCCURRED AS THE SCRUB NURSE DID NOT WITNESS THE EVENT. THE PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other