BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ABBOTT MEDICAL OPTICS INTRAOCULAR LENS

    MDR report key: 4721410 · Received April 22, 2015

    Report

    Report Number
    2648035-2015-00258
    Event Type
    Injury
    Date Received
    April 22, 2015
    Date of Event
    January 1, 2015
    Report Date
    March 31, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED INDICATED THAT THE INVESTIGATION AT THE FACILITY WAS CLOSED. IT WAS DETERMINED THAT THE AMO INTRAOCULAR LENSES (IOLS) (WHICH WERE NEVER FURTHER IDENTIFIED BY BRAND OR SERIAL NUMBER) WERE NOT INVOLVED. IN ALL CASES THE INFLAMMATION CAME FROM THE PATIENT. NO FURTHER INFORMATION IS EXPECTED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT 3 UNIDENTIFIED PATIENTS EXPERIENCED ENDOPHTHALMITIS AFTER BEING IMPLANTED WITH AN UNKNOWN ABBOTT MEDICAL OPTICS INTRAOCULAR LENS (IOL). THIS REPORT REPRESENTS PATIENT #3 WHO HAD AN INCIDENT DATE OF (B)(6) 2015''. NO OTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT FOR EACH OF THE OTHER TWO PATIENTS IS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267944 UNKNOWN ABBOTT MEDICAL OPTICS INTRAOCULAR LENS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other