BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 211846 · Received February 24, 1999

    Report

    Report Number
    1119421-1999-00211
    Event Type
    Other
    Date Received
    February 24, 1999
    Date of Event
    May 30, 1997
    Report Date
    January 26, 1999
    Manufacturer
    ALCON LABORATORIES, INC
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    MEDICAL RECORDS STATE A PATIENT HAD CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT ON 2/19/1997 AND A YAG PROCEDURE ON 5/19/1997 WITH ONE SURGEON. SHE THEN REFERRED HERSELF TO ANOTHER SURGEON. HE AND A RETINAL CONSULTANT SURGEON PERFORMED A VITRECTOMY, INDIRECT OPHTHALMOSCOPIC LASER, 200 SPOTS, AN IOL EXPLANT AND IOL IMPLANT ON 5/30/1997. IT WAS REPORTED THAT THE HAPTIC OF THE EXPLANTED IOL HAD BEEN VISIBLE POSTERIOR TO THE IMPLANT AND FELT TO BE BENT PRIOR TO THE 5/30/1997 SURGERY. THE HAPTIC WAS DISCOVERED TO BE LOOSE AND WAS TOTALLY SEPARATED FROM THE PROXIMAL PORTION OF THE OPTIC DURING THE EXPLANT. DUE TO THE POSITION OF THE HAPTIC IN THE VITREOUS BASE THE SURGEON FELT IT WAS BEST TO LEAVE THE HAPTIC IN ITS POSITION. THE PATIENT HAD FOLLOW-UP VISITS WITH THE SURGEONS. ON HER LAST REPORTED VISIT ON 1/25/1999 MEDICAL RECORDS STATE THE PATIENT'S VISION WAS 20/20 IN HER RIGHT EYE, THE ANTERIOR CHAMBER REACTION WAS 2+ CELL. THE ANTERIOR VITREOUS REACTION WAS 1+ CELL. THE RETINA WAS TOTALLY ATTACHED AND THE HAPTIC REMAINS IN A RELATIVELY STABLE POSITION ON THE INFERIOR PARS PLANA.

    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 47 YR Other PRED FORTE (THERAPY DATES ARE NOT KNOWN).| TIMOPTIC (THERAPY DATES ARE NOT KNOWN).| TRUSOPT (THERAPY DATES ARE NOT KNOWN).| ALPHAGAN (THERAPY DATES ARE NOT KNOWN).