BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAOCULAR LENS

    MDR report key: 35842 · Received August 22, 1996

    Report

    Report Number
    MW1009772
    Event Type
    Malfunction
    Date Received
    August 22, 1996
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SILICONE INTRAOCULAR LENSES ARE FOLDABLE LENSES BEING USED IN CATARACT SURGERY. ONE OF THE PRIMARY CAUSES OF RETINAL DETACHMENT IS PREVIOUS CATARACT SURGERY AND SUBSEQUENT LASER (YAG) CAPSULOTOMY. IN THE REPAIR OF A DETACHED RETINA, A SURGEON OFTEN PERFORMS A VITRECTOMY WITH FLUID AIR EXCHANGE. SILICONE INTRAOCULAR LENSES BECOME "FOGGY" DURING THE EXCHANGE AND THE SURGEON CANNOT SEE THROUGH THE LENS IMPLANT. IN ADDITION, SILICONE OIL IS SOMETIMES USED IN REPAIR OF COMPLEX DETACHMENTS AND THE OIL IS INCOMPATIBLE WITH THE SILICONE LENS. THIS IS GOING TO BECOME A GREATER PROBLEM FOR RETINAL SURGEONS AS MORE OF THESE LENSES ARE USED. RPTR THINKS THE FDA SHOULD CONSIDER DISALLOWING THE USE OF THESE LENSES IN CATARACT SURGERY. IN ADDITION, PTS WITH MACULAR HOLES REQUIRE FLUID AIR EXCHANGE TO REPAIR THE HOLE AND PTS WITH SILICONE IOLS AND OPEN POSTERIOR CAPSULES PRESENT A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAOCULAR LENS Implant INTRAOCULAR LENS HQL ALLERGAN MEDICAL OPTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *