BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AR40E

    MDR report key: 2233502 · Received September 2, 2011

    Report

    Report Number
    2648035-2011-00200
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE OF THE OPTIC RECEIVED WAS LESS THAN HALF OF THE LENS. BASED ON THE ANALYSIS MADE BY ENGINEERING PERSONNEL, WITH THE IOL PIECE PROVIDED, WE WERE NOT ABLE TO MEASURE THE DIOPTER. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND MET ALL SPECIFICATIONS. NO OTHER REPORTS OF A SIMILAR NATURE WERE RECEIVED FOR THE REMAINING LENSES IN THIS PRODUCTION ORDER. CONCLUSION: THE REPORTED COMPLAINT COULD NOT BE VERIFIED, THE OPTIC IS TOO DAMAGED TO CONDUCT A CHECK FOR THE OPTICAL RESOLUTION OR THE DIOPTER OF THE LENS. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE LENS WAS RECEIVED AND IS CURRENTLY UNDER EVALUATION AT THE MANUFACTURING FACILITY. THE RESULTS OF OUR INVESTIGATION ARE INCONCLUSIVE AT THIS TIME. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANT THE PATIENT HAD A +4.5 DIOPTER MISS ON THE RIGHT EYE. CALCULATIONS WERE REPEATED WITH SIMILAR RESULTS. LENS WAS EXPLANTED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AR40E MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS AR40E

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Disability