BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 121390 · Received September 17, 1997

    Report

    Report Number
    1119421-1997-00094
    Event Type
    Injury
    Date Received
    September 17, 1997
    Date of Event
    June 5, 1997
    Report Date
    August 18, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE LENS EVALUATION BY AN INDEPENDENT THIRD PARTY WERE RECEIVED ON 1/12/1998. THE REPORT READS: THE MFT RESULTS OF THE IOL MEET THE MINIMUM ISO REQUIREMENT OF 0.430 AT 100 CYCLES/MM. THE FOCAL LENGTH, RESOLUTION AND MTF OF THE IOL MEET THE SPECIFICATIONS FOR A 23.5 DIOPTER LENS OF THIS MODEL. A MODERATE NUMBER OF VACUOLES WERE OBSERVED WITHIN THE OPTICAL COMPONENT OF THE LENS AS DESCRIBED BY THE REPORTING PHYSICIAN. PENDING THE RESULTS, THE LENS WAS RETURNED TO THE MFR. EVALUATION REVEALED THE FOCAL LENGTH, RESOLUTION AND MTF WERE WITHIN SPECIFICATIONS FOR A 23.5 DIOPTER LENS OF THIS MODEL. THIS REPORT WAS MAILED IN TO FDA ON: 2/10/1998.

    Description of Event or Problem · 1

    SURGEON REPORTS LENS EXPLANTED DUE TO GLISTENINGS WHICH WERE CAUSING BLURRY, "WATERY" VISION. SYMPTOMS RESOLVED UPON IMPLANTATION OF PMMA LENS. EXPLANTING SURGEON WAS NOT THE ORIGINAL IMPLANTING SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF Implant INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. MA60BM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention