BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2241890 · Received September 9, 2011

    Report

    Report Number
    2648035-2011-00204
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    PP99080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED IOL WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED, 20.5. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. A REVIEW OF THE MANUFACTURER'S IMPLANT DATABASE SHOWS THE ORIGINAL IMPLANT WAS REPLACED WITH A HIGHER DIOPTER LENS OF THE SAME MODEL. 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.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE INTRAOCULAR LENS (IOL) WAS EXPLANTED (B)(6) AFTER IMPLANT DUE TO IMPROPER IOL POWER. NO PATIENT INJURY OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention