BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 4122086 · Received September 26, 2014

    Report

    Report Number
    2648035-2014-00503
    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 PERFORMED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH THE MANUFACTURING INSTRUCTIONS SPECIFICATIONS. NO DEVIATION OR NONCONFORMANCE (NCR) RELATED TO THE CUSTOMER REPORT WAS GENERATED. THE PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT LENS MODEL IN THE EVENT DESCRIPTION WAS CORRECTED TO AN AR40MN. MODEL# AR40MN. CONCOMITANT PRODUCT: EMERALDXL INSERTER (UNFOLDER / HANDPIECE) LOT # CP00848. 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 AN AR40M 7.0 DIOPTER INTRAOCULAR LENS (IOL) WAS LOADED CORRECTLY INTO AN EMERALD XL INSERTER BUT THE HAPTIC RIPPED OFF ONCE IMPLANTED INTO THE EYE. THE PHYSICIAN THEN EXTRACTED THE LENS FROM THE EYE BY ENLARGING THE INCISION FROM 2.4 TO 3.0. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AR40MN 7.0 DIOPTER INTRAOCULAR LENS (IOL) WAS LOADED CORRECTLY INTO AN EMERALDXL INSERTER BUT THE HAPTIC RIPPED OFF ONCE IMPLANTED INTO THE EYE. THE PHYSICIAN THEN EXTRACTED THE LENS FROM THE EYE BY ENLARGING THE INCISION FROM 2.4 TO 3.0. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601081 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40MN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EMERALDXL INSERTER LOT # CP00848