BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT MEDICALS OPTICS

    MDR report key: 4274223 · Received November 7, 2014

    Report

    Report Number
    2027748-2014-00003
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    October 8, 2014
    Report Date
    November 6, 2014
    Manufacturer
    AAREN SCIENTIFIC INC
    Product Code
    HQL
    PMA / PMN Number
    P010027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REVIEWED THE DEVICE HISTORY RECORD AND THERE WERE NO NON-CONFORMITIES OR DEVIATIONS NOTED DURING THE MANUFACTURING OF THE LENS THAT COULD HAVE CONTRIBUTED TO THIS ADVERSE EVENT. THE DEVICE WAS NOT AVAILABLE TO BE EVALUATED AFTER. THE DOCTOR SPECIFIED THAT THE BLEEDING WAS NOT CAUSED BY THE SURGERY OR THE DEVICE. THE BLEEDING WAS DUE TO PATIENT PATHOLOGY. CORRECTION MADE TO CODE WAS ADDED TO CAPTURE THAT THERE WAS NO DEVICE MALFUNCTION. ADVERSE EVENT HAD NO DEVICE RELATIONSHIP, BUT WAS RELATED TO THE PROCEDURE AND PATIENT PATHOLOGY.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD FOR THE LENS WAS REVIEWED AND FOUND NO NONCONFORMITIES OR DEVIATIONS. LENS WAS MANUFACTURED PER CURRENT STANDARD OPERATING PROCEDURES AND MET ALL EXPECTED CRITERIA FOR RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, INCISION ENLARGEMENT AND VITRECTOMY WERE CONDUCTED. IT WAS STATED THAT UNCONTROLLED BLEEDING WAS FROM PT PATHOLOGY AND WAS NOT PRODUCT OR SURGERY RELATED. IT WAS EXPLAINED THAT THE LENS WAS NOT FULLY IMPLANTED BUT WAS IN CONTACT WITH PT AND IN THE PROCESS OF INSERTION WHEN EVENT HAPPENED. DOCTOR ENLARGED INCISION TO HELP REMOVE THE LENS. A SECOND LENS WAS NOT IMPLANTED. PT WENT HOME APHAKIC. THE PT IS FINE WITH NO REAL PROBLEMS, AND BELIEVED PT WILL BE IN SURGERY (B)(6) 2014 TO HAVE A LENS IMPLANTED AT ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717375 ABBOTT MEDICALS OPTICS INTRA-OCULAR LENS HQL AAREN SCIENTIFIC INC AC21B-130 7293081307

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other