BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2210979 · Received August 12, 2011

    Report

    Report Number
    2648035-2011-00165
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS WAS MEASURED FOR POWER AND CONFIRMED TO BE A 14.0 DIOPTER AS LABELED. ALL OTHER OPTICAL PROPERTIES MET SPECIFICATIONS. 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 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 WITHOUT PATIENT COMPLICATIONS 1 MONTH AFTER IMPLANT. THE LENS WAS EXPLANTED DUE TO IMPROPER IOL POWER.

    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 59 YR Required Intervention