BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 4221178 · Received November 3, 2014

    Report

    Report Number
    2648035-2014-00585
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO INITIAL REPORT, INFORMATION THAT WAS KNOWN BUT INADVERTENTLY NOT PROVIDED. (B)(6). CONCOMITANT PRODUCT: UNFOLDER CARTRIDGE EMERALDC30 LOT NUMBER: UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED TO THE MANUFACTURER. THE MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT DURING THE IMPLANTATION OF AN (B)(4), THE LEADING HAPTIC WAS IN THE EYE WHEN THE SURGEON NOTICED THE HAPTIC WAS BENT. THE INCISION WAS ENLARGED AND THE INTRAOCULAR LENS (IOL) WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703330 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention