BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS

    MDR report key: 830738 · Received March 23, 2007

    Report

    Report Number
    1313525-2007-00059
    Event Type
    Injury
    Date Received
    March 23, 2007
    Date of Event
    March 1, 2007
    Report Date
    March 12, 2007
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MUW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED AND NO LOT NUMBER INFO WAS PROVIDED. THE PT CHANGED THE WATER IN HER FISH TANK AND REPORTED SPLASHING WATER INTO HER EYES THE NIGHT PRIOR TO THE ONSET. IT WAS REPORTED THE EVENT "HAS NOTHING TO DO WITH" THE LENSES.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTS THAT AN EYECARE PRACTITIONER FIT A PT WITH A TRIAL PAIR OF LENSES FOR OVERNIGHT. THE PT CHANGED THE WATER IN HER FISH TANK THAT NIGHT AND ACCIDENTALLY SPLASHED WATER INTO HER EYES. THE FOLLOWING DAY, SHE PRESENTED TO THE HCP WITH COMPLAINTS OF DISCOMFORT IN ONE EYE AND SHE WAS TOLD TO DISCONTINUE USE OF THE CONTACT LENSES. THE DISCOMFORT PERSISTED AND THE PT PRESENTED TO HER GENERAL PRACTITIONER WHO PRESCRIBED TETRACYCLINE APPLICATION TO HER EYES. THE CONDITION WORSENED THE FOLLOWING DAY AND THE PT PRESENTED TO THE EYE HOSP. THE OPHTHALMOLOGIST EXAMINED THE EYE TISSUE AND INSPECTED THE CONTACT LENSES. THE PT WAS DIAGNOSED WITH A FUNGAL INFECTION. IT WAS REPORTED THAT THE EVENT "HAS NOTHING TO DO WITH" THE CONTACT LENSES. THE PT IS NOW UNDER CLOSE OBSERVATION AND IF NO IMPROVEMENT, A CORNEAL TRANSPLANT MAY BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS GAS PERMEABLE CONTACT LENS MUW BAUSCH & LOMB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention