BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2150201 · Received July 6, 2011

    Report

    Report Number
    2648035-2011-00128
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    March 16, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT RECEIVED FOR ANALYSIS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ATTEMPTS WILL CONITINUE TO OBTAIN ADDITIONAL INFORMATION FROM THE ACCOUNT. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED FOR INSPECTION. VISUAL INSPECTION SHOWS A LENS CUT IN HALF WITH ONE DISTORTED HAPTIC AND DRIED CONTAMINATION ON THE OPTIC. THE CONDITION OF THE RETURNED LENS PRECLUDED MEASURING THE DIOPTER. OUR INVESTIGATION CONFIRMED THE ORIGINAL IMPLANT OF 22.5 DIOPTERS WAS REPLACED WITH A 20.5 DIOPTER LENS OF THE SAME MODEL SUGGESTING THIS EVENT WAS NOT CAUSED BY THE IOL. INFORMATION RECEIVED FROM THE REPORTER STATED THE INCORRECT DIOPTER WAS IMPLANTED, NO PATIENT INJURY OCCURRED DURING THE EXCHANGE PROCEDURE. 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

    A NURSE REPORTED THE INTRAOCULAR LENS WAS EXCHANGED WITH AN UNIDENTIFIED LENS 3 MONTHS AFTER IMPLANT . REASON STATED WAS INCORRECT DIOPTER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE TO DATE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention