BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR

    MDR report key: 3942117 · Received July 17, 2014

    Report

    Report Number
    2648035-2014-00353
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND GENDER - NOT PROVIDED/UNKNOWN. DATE OF EVENT - NOT PROVIDED/UNKNOWN. DATE OF IMPLANT AND EXPLANT - NOT PROVIDED/UNKNOWN. INITIAL REPORTER: PHONE NUMBER OF REPORTER - (B)(6). (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 FOR SERIAL NUMBER (B)(4). RESULTS REVEALED 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. THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. 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 DAY POST IMPLANT THE PHYSICIAN OBSERVED THAT THE AR40E 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS DECENTERED WITH THE HAPTIC IN THE ANTERIOR CHAMBER OF THE EYE. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER AR40E LENS OF THE SAME DIOPTER POWER. THE PATIENT IS OKAY NOW. THE EXPLANTED LENS WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR EVALUATION. THE PATIENT'S VISUAL ACUITY IS 0,7 (AS EXPECTED). THERE WAS NO INCISION ENLARGEMENT AND THE IOL WAS TAKEN OUT IN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418513 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention