BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR

    MDR report key: 3953946 · Received July 23, 2014

    Report

    Report Number
    2648035-2014-00371
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT, EXPLANT DATES: UNKNOWN. THE DEVICE NOR ITS PACKAGING WAS RETURNED TO THE MANUFACTURER. THE SALES REPRESENTATIVE PROVIDED PHOTOGRAPHS OF THE OUTER PACKAGING WHICH WERE EVALUATED. MANUFACTURING RECORD REVIEW IS PENDING. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DOCUMENTATION SHOWED ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH PRODUCT SPECIFICATIONS. ALL TEST RESULTS SHOWED A PASS CONDITION. NO DEVIATIONS OR NON-CONFORMANCES (NCR) WERE FOUND. NO DEVIATION OR NON-CONFORMITY DOCUMENTED IN THE PRODUCTION ORDER WERE FOUND DURING THE AMO MANUFACTURING LABELING/BOXING PROCESS. A REVIEW OF THE PROCESS AND/OR MATERIAL CHANGE DOES NOT SHOW A CHANGE IN MANUFACTURING METHOD, INSPECTIONS OR SPECIFICATIONS. PRODUCT MET MANUFACTURING CRITERIA PRIOR TO RELEASE. THERE WERE NO DISCREPANCIES IDENTIFIED IN THE DOCUMENTATION REVIEWED. NO LABELING/PACKAGING ISSUES WERE REPORTED. THE CUSTOMER CLAIM IS RELATED TO CHINESE LABEL INSTEAD OF AMO LABEL. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A PATIENT'S DAUGHTER NOTED THAT THE LABELS ON THE INTRAOCULAR LENSES (IOLS) USED DURING HER FATHER'S CATARACT SURGERY WERE DIFFERENT. THE PATIENT HAD TWO IOLS IMPLANTED AND ONE LABEL WAS DIFFERENT FROM THE OTHER. HER FATHER WAS NOT EXPERIENCING ANY DISCOMFORT OR SIDE EFFECTS AFTER THE IMPLANTATION OF THE DEVICES. PER (B)(4) REGULATIONS, ALL IMPORTED PRODUCTS NEED THE (B)(4) LABEL AND DIRECTIONS FOR USE. THE DEVICE IS OVER-LABELED IN (B)(4) AT A DISTRIBUTION CENTER AND THEN SHIPPED TO (B)(4). FROM THE PICTURES THAT THE AMO SALES REPRESENTATIVE SENT IT WAS DETERMINED THAT THE (B)(4) LABEL USED ON TWO IOLS IS NOT THE ONE APPROVED BY AMO. THE EVENT IS BEING INVESTIGATED BY AMO GLOBAL PRODUCT PROTECTION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431181 SENSAR MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1