BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU FRESH MULTI-PURPOSE SOLUTION

    MDR report key: 2446008 · Received February 6, 2012

    Report

    Report Number
    1313525-2012-00004
    Event Type
    Injury
    Date Received
    February 6, 2012
    Report Date
    February 2, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. THE ARTICLE NOTED TWO DAYS PRIOR TO EVENT, PT WENT SWIMMING IN A HOME POOL, REMOVED LENSES WHILE SWIMMING AND STORED THEM IN A OLD STORAGE CASE WITH UNPRESERVED SALINE. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ARTICLE REPORTS A (B)(6) FEMALE PRESENTED WITH A RED, PAINFUL LEFT EYE. SLIT LAMP EXAM FOUND THE EYE TO HAVE EPITHELIAL DEFECT, PUNCTATE STAINING, WIDESPREAD CORNEAL INFILTRATE, CENTRAL HYPOPYON, AND LID EDEMA. PT WAS DIAGNOSED WITH CONTACT LENS RELATED MICROBIAL KERATITIS WITH A HIGH SUSPICION FOR ACANTHAMOEBA KERATITIS. THE CORNEAL SIGNS WERE COMMENSURATE WITH ACANTHAMOEBA KERATITIS. PT WAS ADMITTED TO HOSPITAL FOR TEN DAYS OF INTENSIVE ANTIMICROBIAL TREATMENT. TWO DAYS BEFORE PRESENTATION, PT WENT SWIMMING IN A HOME POOL, REMOVED LENSES WHILE SWIMMING AND STORE THEM IN A OLD STORAGE CASE WITH UNPRESERVED SALINE. LENSES WERE REINSERTED THE NEXT DAY. AT (B)(6) EXAM, A DIFFUSE CENTRAL SUBEPITHELIAL SCAR REMAINED, MEDICATION CEASED AND PT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU FRESH MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R PUREVISION (BALAFILCON A) CONTACT LENS