BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 273126 · Received April 7, 2000

    Report

    Report Number
    1119421-2000-00298
    Event Type
    Other
    Date Received
    April 7, 2000
    Report Date
    March 6, 2000
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED SEEING STARBURSTS AT NIGHT FOLLOWING CATARACT SURGERY. THE SURGEON PRESCRIBED PILOCARPINE WITHOUT RELIEF OF THE SYMPTOMS.

    Description of Event or Problem · 1

    ADDITIONAL INFO PROVIDED BY THE SURGEON STATED THAT THE PT HAD GLARE SYMPTOMS PRIOR TO IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THE PT ALSO HAD A TRABECULECTOMY SOMETIME PRIOR TO IMPLANTATION SURGERY.

    Description of Event or Problem · 1

    ADD'L INFO PROVIDED BY THE REPORTING SURGEON INDICATES THE PT EXPERIENCED POSTERIOR VITREOUS DETACHMENT FOLLOWING IOL EXCHANGE. THE REPLACEMENT IOL WAS PLACED IN THE SULCUS. VISUAL ACUITY ON 20/28/02 WAS 20/25+2.

    Description of Event or Problem · 1

    THE PT PROVIDED ADD'L INFO INDICATING THE INTRAOCULAR LENS WAS EXCHANGED. PT STATED THE SYMPTOMS OF GLARE AND STARBURST RESOLVED FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other