BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOCULAR LENS REXOOM RIGHT

    MDR report key: 1003380 · Received February 22, 2008

    Report

    Report Number
    MW5005662
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    MULTIFOCAL IOL -REZOOM MANUFACTURED BY ADVANCED MEDICAL OPTICS-LENSES WERE IMPLANTED IN 2006 DURING REMOVAL OF CATARACTS IN THE RIGHT AND LEFT EYE. ALMOST IMMEDIATELY I EXPERIENCED A WORLD OF HALOS, GLARE, GHOSTING AND STARBURSTS. ONLY NATURAL SUNLIGHT WOULD LET ME EXPERIENCE GOOD VISION. IN ANY ENVIRONMENT THAT REQUIRED ARTIFICIAL LIGHT, MY VISION WAS SIMILAR TO "LOOKING THROUGH SARAN WRAP." I EXPERIENCED EPISODES OF VERTIGO WHEN THE AMBIENT LIGHT CHANGED. I WAS/AM NIGHT BLIND. MY NEAR VISION IS NOW MARGINAL AT BEST DURING SHORT PERIODS OF TIME -5 TO 10 MINUTES- AND REQUIRED DIFFERENT SETS OF GLASSES DEPENDING ON THE LIGHTING. I AM/WAS A PRACTICING GENERAL DENTIST WHO WITHIN SEVERAL WEEKS HAD TO GO ON DISABILITY. I WAS TOLD THE LENSES WERE "STATE OF THE ART" AND PAID AN EXTRA AND BEYOND WHAT MY INSURANCE COVERED. I WAS TOLD TO BE PT AND CONDITIONS WOULD IMPROVE.. WHICH DID NOT HAPPEN. THEN I WAS TOLD BY SEVERAL SPECIALISTS MY ONLY COURSE OF ACTION IS EXPLANTATION OF THESE LENSES. I WENT ON A SEARCH AT THIS TIME - 2007-TO FIND A SKILLED SURGEON WITH EXPERTISE IN REMOVING THESE REZOOM IMPLANTS ONLY TO FIND NO OPHTHALMOLOGISTS WOULD HAD ALREADY REMOVED THESE TYPE OF LENSES. SUDDENLY I DEVELOPED IN THE RIGHT EYE ACUTE EXUDATIVE MACULAR DEGENERATION WHICH NECESSITATED IMMEDIATE INTRAOCULAR INJECTIONS OF AVASTIN TO ARREST THE BLEEDING IN THE RETINA. AFTER 4 OR 5 MONTHS OF INJECTIONS, THE RETINAL SPECIALISTS WERE ABLE TO STABILIZE THE BLEEDING WITH MINIUM DAMAGE TO THE EYE. BECAUSE OF THE SERIOUSNESS OF THE COMPLICATIONS THAT FOLLOWED THE FIRST IMPLANT OF THE REZOOM REMOVAL OF THE LENSES IS TOO RISKY A PROCEDURE AND NOW I REMAIN A DISABLED DEPRESSED DENTIST. DATES OF USE # 2006 - 2007. DIAGNOSIS OR REASON FOR USE: REPLACEMENT OF CATARACT LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAOCULAR LENS REXOOM RIGHT DIOPTER 20.5 HQL ADVANCED MEDICAL OPTICS NXG1
    2 INTROCULAR LENS REZOOM LEFT DIOPTER 20.5 HQL ADVANCED MEDICAL OPTICS NXG1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention NO OTHER PRODUCTS INVOLVED