BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAOCULAR LENS

    MDR report key: 6456338 · Received April 4, 2017

    Report

    Report Number
    6456338
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    November 21, 2016
    Report Date
    March 8, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS INC. (AMO)
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO LOAD INTRAOCULAR LENSES FOR IMPLANTATION AFTER CATARACTS WERE REMOVED, DURING THE SURGERY, MULTIPLE CARTRIDGES WERE NOTED TO BE DEFECTIVE (4 LENSES ACTUALLY GOT STUCK AND 2 LENSES WERE FELT TO BE VERY "TIGHT" WHILE INSERTING THEM). TWO PATIENTS REQUIRED TWO LENSES TO BE OPENED (THOUGH ONLY ONE WAS IMPLANTED IN EACH PATIENT) AND A THIRD PATIENT REQUIRED 3 LENSES TO BE OPENED, AGAIN ONLY ONE WAS IMPLANTED. THE NURSE CALLED THE COMPANY REP ABOUT IT AND THE REP SAID IT SOUNDED AS IF THERE WAS NO SILICONE ON THE INSIDE OF THE CARTRIDGES AND THAT HE WOULD SEND OUT AN "ALERT". THE HOSPITAL "BORROWED" A DOZEN CARTRIDGES FROM A SISTER FACILITY IN THE AREA AND FINISHED THE DAYS SCHEDULE WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238281 INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS INC. (AMO) CB39355

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES