BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 303325 · Received November 2, 2000

    Report

    Report Number
    MW1020334
    Event Type
    Injury
    Date Received
    November 2, 2000
    Date of Event
    August 3, 2000
    Manufacturer
    CILCO ALCON LABORATORIES, INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WAS DIAGNOSED WITH CATARACTS IN BOTH EYES THE CATARACT WAS EXTRACTED FROM THE LEFT EYE AND AN ARRAY MULTIFOCAL INTRAOCULAR LENS WAS IMPLANTED. BEST-UNCORRECTED VISUAL ACUITY WAS 20/25 AT ONE-WEEK POST SURGERY. AROUND THREE TO FOUR WEEKS POST SURGERY THE PT'S BEST UNCORRECTED VISUAL ACUITY WORSENED TO 20/50-20/60 DUE TO A POSSIBLE SHIFT OF THE INTRAOCULAR LENS. IN ADDITION, FROM THE TIME OF IMPLANTATION, THE PT EXPERIENCED HALOS AROUND POINT SOURCES OF LIGHT UNDER NIGHTTIME (DARK/LOW LIGHT) CONDITIONS. 8 MONTHS LATER THE PT'S BEST-UNCORRECTED VISUAL ACUITY HAD NOT IMPROVED AND THE HALOS WERE A PERSISTENT DISABILITY FOR NIGHT DRIVING. THE INTRAOCULAR LENS WAS EXPLANTED AND AN ALCON INTRAOCULAR LENS (MZ60BD) WAS IMPLANTED. ONE DAY POST SURGERY THE BEST UNCORRECTED VISUAL ACUITY WAS 20/30 AND THE PT EXPERIENCED LIGHT STREAKS/HALOS AROUND POINT SOURCES OF LIGHT UNDER NIGHTTIME CONDITIONS. ONE WEEK POST SURGERY THE PT'S BEST UNCORRECTED VISUAL ACUITY WAS 20/70-20/80. AS OF 3 MONTHS LATER THE PT'S VISUAL ACUITY HAD NOT IMPROVED AND THE LIGHT STREAKS/HALOS ARE A PERSISTENT DISABILITY FOR NIGHT DRIVING. PT IS UNAWARE IF THIS EVENT HAS BEEN REPORTED. THE PT IS NOW USING ANOTHER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INTRAOCULAR LENS HQL CILCO ALCON LABORATORIES, INC. MZ60BD POWER: 20.0 D OPTIC (0B): 6.0 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability