BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERISYSE OR ARTISAN PHAKIC INTRAOCULAR LENS

    MDR report key: 3251802 · Received July 18, 2013

    Report

    Report Number
    8040449-2013-00001
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 18, 2013
    Manufacturer
    OPHTEC BV
    Product Code
    MTA
    PMA / PMN Number
    P030028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT RECEIVE BILATERAL PHAKIC LENS IMPLANTS IN EYES THAT DID NOT MEET THE MINIMUM ESTABLISHED ANTERIOR CHAMBER DEPTH AND ENDOTHELIAL CELL DENSITY AS STATED IN THE FDA APPROVED PRODUCT LABELING. THE PT ACHIEVED 20/20 VISION IN BOTH EYES POSTOPERATIVELY AND DID NOT HAVE ANY POST IMMEDIATE OPERATIVE COMPLICATIONS. THE PT WAS NOT SEEN AGAIN BY THE SURGEON FOR 8 YEARS. THE PT PRESENTED 8 YEARS POSTOPERATIVE WITH IDIOPATHIC CORNEAL EDEMA AND ENDOTHELIAL CELL DENSITIES LOWER THAN EXPECTED. ALTHOUGH NO INFO IS AVAILABLE TO DETERMINE WHETHER OR NOT THE LENS IMPLANTS CAUSED OR PLAYED A ROLL IN THE DEVELOPMENT OF CORNEAL EDEMA OR REDUCTION IN ENDOTHELIAL CELL DENSITY, THE MFR AGREES WITH THE SURGEON'S TREATMENT TO REMOVE THE LENSES AS A PRECAUTIONARY MEASURE.

    Description of Event or Problem · 1

    PT PRESENTED 8 YEARS POSTOPERATIVE (AFTER RECEIVING BILATERAL PHAKIC INTRAOCULAR LENS IMPLANTS), WITH IDIOPATHIC CORNEAL EDEMA AND LOWER THAN EXPECTED ENDOTHELIAL CELL COUNTS IN BOTH EYES. THE TREATMENT PLAN IS TO REMOVE THE LENSES AS A PRECAUTIONARY MEASURE AND TO SIMULTANEOUSLY PERFORM CLEAR LENS EXTRACTIONS AND IMPLANT POSTERIOR CHAMBER INTRAOCULAR LENSES TO CORRECT THE PT'S REFRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335284 VERISYSE OR ARTISAN PHAKIC INTRAOCULAR LENS PHAKIC INTRAOCULAR LENS MTA OPHTEC BV BRSM6US

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention