BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE

    MDR report key: 1080379 · Received July 21, 2008

    Report

    Report Number
    1033553-2008-00079
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    October 1, 2005
    Report Date
    July 22, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE PT SENT AN EMAIL TO REPORT THE FOLLOWING INFO: "I HAD A 1-DAY PARTIALLY STICK TO MY EYE RESULTING IN A 3/4 CIRCLE TEAR OF THE CORNEA AND HAD TO BE FITTED WITH A SPECIAL "BANDAID" CONTACT IN ORDER TO HEAL. I WAS UNABLE TO SEE WITH THAT EYE FOR NEARLY TWO WEEKS. PLEASE ADVISE PTS THAT THIS IS A RARE BUT VERY REAL COMPLICATION. MY EYE HAD BEEN IRRITATED AND I WAS ANXIOUS TO REMOVE THE LENS, I DIDN'T REALIZE IT WASN'T FLOATING FREE UNTIL IT WAS TOO LATE. EXTREMELY PAINFUL! I STILL SOMETIMES HAVE ONE STICK, BUT PATIENTLY WAIT FOR THE DROPS TO LUBRICATE PRIOR TO REMOVAL." TREATING OPHTHALMOLOGIST'S CHART INDICATES THAT THE PT PRESENTED SOMETIME IN 2005 AS AN E.R. REFERRAL. CHART NOTES A LARGE CENTRAL CORNEAL ABRASION OD WITH SOME CORNEAL EROSION. THE PT WAS TREATED WITH VIGAMOX GTTS EVERY TWO HOURS AND BANDAGE CONTACT LENS. THE PT WAS SEEN FOR TWO ADDITIONAL FOLLOW UP VISITS; CHART NOTES "IMPROVED." PT HAS NOT BEEN SEEN SINCE THAT TIME. LOT NUMBER OF THE PRODUCT IN QUESTION IS UNK AND PT DISCARDED THE PRODUCT IN QUESTION. NO ADDITIONAL INFO IS EXPECTED TO BE RECEIVED. WILL REPORT ANY ADDITIONAL INFO WITHIN 30 DAYS SHOULD ANY ADDITIONAL INFO BECOME AVAILABLE. ALL REPORTABLE ADVERSE EVENTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE SOFT CONTACT LENS LPL VISTAKON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention