BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 4123016 · Received September 26, 2014

    Report

    Report Number
    2648035-2014-00504
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED. THE INTRAOCULAR LENS (IOL) MANUFACTURING REVIEW SHOWED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTION SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER'S REPORT WERE GENERATED WHEN THIS PRODUCTION ORDER WAS MANUFACTURED. THE PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER .

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE HAPTIC OF AN AR40MN 7.0 DIOPTER INTRAOCULAR LENS SNAPPED IN HALF DURING LENS LOADING. THE LENS WAS INSERTED AND REMOVED REQUIRING INCISION ENLARGEMENT FROM 2.4 TO 3.0. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600373 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40MN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EMERALD XL INSERTER LOT# CPOO848