BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 105321 · Received July 10, 1997

    Report

    Report Number
    1119421-1997-00063
    Event Type
    Injury
    Date Received
    July 10, 1997
    Date of Event
    June 18, 1997
    Report Date
    June 20, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE LENS EVALUATION BY AN INDEPENDENT THIRD PARTY WERE RECEIVED ON 01/12/1998. THE REPORT READS: THE MFT RESULTS OF THE IOL MEET THE MINIMUM ISO REQUIREMENTS OF 0.430 AT 100 CYCLES/MM. THE FOCAL LENGTH, RESOLUTION AND MTF OF THE IOL MEET THE SPECIFICATION FOR A 20.0 DIOPTER LENS OF THIS MODEL. PENDING THESE RESULTS, THE LENS WAS RETURNED TO THE MANUFACTURER. EVALUATION REVEALED THE FOCAL LENGTH, RESOLUTION ANF MFT WERE WITHIN SPECIFICATIONS FOR A 20.0 DIOPTER LENS OF THIS MODEL. THIS REPORT WAS MAILED IN TO FDA ON: 02/10/1998. NUMBER OF PERSONS AFFECTED=1.

    Description of Event or Problem · 1

    SURGEON REPORTS PT'S CURRRENT VISUAL ACUITY IS 20/30+2 AFTER LENS REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF Implant INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. MA30BA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention