BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOCRO INCISION VACUUM PHACO PACK

    MDR report key: 3851838 · Received April 11, 2014

    Report

    Report Number
    1920664-2014-00064
    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
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS DISCARDED THE PRODUCT, IT IS NOT AVAILABLE FOR EVALUATION. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. THIS REPORT IS RELATED TO THE EVENT REPORTED ON MDR 1920664-2014-00058, 00059, 00060, 00061, 00062, 00063 AND 00065.

    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
    221262 MOCRO INCISION VACUUM PHACO PACK HQC HQC BAUSCH & LOMB BL5114 V2053

    Patients

    Seq Age Sex Outcome Treatment
    1