BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON CLEANER

    MDR report key: 128227 · Received October 24, 1997

    Report

    Report Number
    1313525-1997-00007
    Event Type
    Injury
    Date Received
    October 24, 1997
    Date of Event
    September 3, 1997
    Report Date
    September 22, 1997
    Manufacturer
    POLYMER TECHNOLOGY CORP.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS USED THIS PRODUCT FOR SEVEN YRS AND IS FAMILIAR WITH THE CARE AND MAINTENANCE OF HER RGP CONTACT LENSES. SHE INADVERTENTLY USED THE CLEANER TO WET HER LENS PRIOR TO INSERTION. SHE PLACED THE CLEANER DIRECTLY ON THE CONTACT LENS AND INSERTED IT INTO HER EYE. SHE EXPERIENCED IMMEDIATE PAIN AND BEGAN FLUSHING HER EYE WITH WATER. HER EYE CONTINUED TO BURN, STING AND SWELL SO SHE WENT TO AN EYE CARE PRACTITIONER WHO DIAGNOSED A CORNEAL ABRASION AND IRITIS O.S. AT A FOLLOW UP VISIT TWO DAYS LATER, THE ABRASION WAS HEALING AND THE IRITIS WAS STILL PRESENT. A FOLLOW UP WAS SCHEDULED FOR 6 MOS FOR REFRACTION. THE OPHTHALMOLOGIST REPORTED THAT NO ADD'L FOLLOW UP WAS REQUIRED FOR THIS EVENT. THE CONSUMER REPORTS THE CONDITION CLEARED AND SHE RESUMED LENS WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON CLEANER RGP CONTACT LENS CLEANER LPN POLYMER TECHNOLOGY CORP. NA GC5158

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention RGP CONTACT LENS.