BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2210969 · Received August 12, 2011

    Report

    Report Number
    2648035-2011-00166
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED IOL WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. 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 SITE. LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE AMO IMPLANT DATABASE SHOWS THE LENS WAS EXCHANGED FOR A HIGHER DIOPTER LENS OF THE SAME MODEL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS EXPLANTED WITHOUT COMPLICATION 4 YEARS AFTER IMPLANT. REASON STATED WAS THE PATIENT'S POST OPERATIVE HYPEROPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention