BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 109503 · Received July 28, 1997

    Report

    Report Number
    1119421-1997-00068
    Event Type
    Injury
    Date Received
    July 28, 1997
    Date of Event
    June 12, 1997
    Report Date
    June 26, 1997
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE LENS EVALUATION BY AN INDEPENDENT THIRD PARTY WERE RECEIEVED ON 01/12/1988. THE REPORT READS: THE MFT RESULTS OF THE IOL MEET THE MINIMUM REQUIREMENT OF 0.430 AT 100 CYCLES/MM. THE FOCAL LENGTH, RESOLUTION ANF MFT OF THE IOL MEET THE SPECIFICATION FOR A 24.5 DIOPTER LENS OF THIS MODEL. PENDING THESE RESULTS, THE LENS WAS RETURNED TO THE MANUFACTURER. EVALUATIONS REVEALED THE FOCAL LENGTH, RESOLUTION, AND THE MFT WERE WITHIN SPECIFICATION FOR A 24.5 DIOPTER LENS OF THIS MODEL. THIS REPORT WAS MAILED IN TO DA ON: 02/10/1998. NUMBER OF PERSONS AFFECTED+1.

    Description of Event or Problem · 1

    SURGEON REPORTS LENS WAS EXPLANTED. THE LENS WAS IMPLANTED ON 9/28/95 WITH A POST-OPERATIVE VISUAL ACUITY (VA) OF 20/25. IN MAR 1996 THE PT WAS DIAGNOSED WITH EPIRETINAL MEMBRANE AND MACULAR PUCKER BY A RETINAL SPECIALIST AND VA WAS 20/70. IN APR 1996 THE PT UNDERWENT POSTRIOR SEGMENT SURGERY INCLUDING A SCLERAL BUCKLE PROCEDURE. VA WAS 20/200 IN MAY 1996 AND IMPROVED TO 20/50 IN AUG 1996 AT WHICH TIME GLISTENINGS WERE NOTED IN THE LENS. BY OCT 1996 VA HAD IMPROVED TO 20/25. IN MAR 1997 VA WAS REPORTED TO HAVE DECREASED TO 20/50 AND THE PT WAS EXPERIENCING DIPLOPIA. A REFRACTION READING REVEALED THAT THE PT WAS NOW -2.50 DIPTERS, APPARENTLY DUE TO THE RETINAL BUCKLE PROCEDURE AND RESULTING CHANGES IN AXIAL LENGTH. THE MOST LIKELY CAUSE OF THE DIPLOPIA WAS DUE TO THE PT'S ANISOMETROPIA. THE LENS WAS EXPLANTED ON 6/12/1997 AND A DIFFERENT LENS POWER IMPLANTED. THE PT'S VISION IMPROVED POST-OPERATIVELY. THE SURGEON IS NOW QUESTIONING THE RELATIONSHIP OF THE PT'S SYMPTOMS TO THE EXPLANTED LENS DUE TO THE IMPROVEMENT IN HER QUALITY OF VISION AFTER THE LENS WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention