BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PHACO PACK

    MDR report key: 3851833 · Received April 11, 2014

    Report

    Report Number
    1920664-2014-00061
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 13, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) STATING: SLEEVE DOES NOT ENTER A 1.8 INCISION. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221236 MICRO INCISION VACUUM PHACO PACK HQC HQC BAUSCH & LOMB BL5114 V2053

    Patients

    Seq Age Sex Outcome Treatment
    1