BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON ADVANCE CONDITIONING SOLUTION

    MDR report key: 2421261 · Received January 11, 2012

    Report

    Report Number
    1313525-2012-00002
    Event Type
    Injury
    Date Received
    January 11, 2012
    Report Date
    September 27, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LYL
    PMA / PMN Number
    P920055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. THE LOT NUMBER IS UNK. THE ARTICLE NOTED THAT THE PT DID NOT FULLY COMPLY WITH PROPER LENS CARE MAINTENANCE. BASED ON ALL INFO, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ARTICLE STATED A (B)(6) FEMALE PT PRESENTED WITH OCULAR PAIN, BLURRED VISION, EYELID SWELLING, AND FOREIGN BODY SENSATION IN THE RIGHT EYE. PT WAS INITIALLY MIS-DIAGNOSED AND TREATED FOR POSSIBLE VIRAL KERATITIS DUE TO (B)(6). PT DID NOT RESPOND TO TREATMENT AND SIX WEEKS LATER, CORNEAL SCRAPINGS WERE POSITIVE FOR (B)(6). PT WAS TREATED WITH CHLORHEXIDINE, PROPAMIDINE, AND CYCLOPLEGIC EYE DROPS WHICH RESULTED IN SIGNIFICANT IMPROVEMENT. PT FOLLOWED TREATMENT FOR THREE MONTHS AND POSSIBLY TO CONTINUE FOR A YEAR. UPON QUESTIONING, THE PT STATED USED TAP WATER TO "WASH" THE LENSES AND HER OWN SALIVA TO MOISTEN THEM. THE LENSES AND LENS CASE WERE APPROX 10 YRS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON ADVANCE CONDITIONING SOLUTION LYL BAUSCH + LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R BOSTON ADVANCED CLEANER