BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU FRESH MULTI-PURPOSE SOLUTION

    MDR report key: 3037649 · Received March 28, 2013

    Report

    Report Number
    1313525-2013-00002
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION, HOWEVER, THE COMPLAINT SAMPLE WAS INSUFFICIENT TO PERFORM ALL TESTING. PRELIMINARY EVALUATION RESULTS OF THE TESTING PERFORMED FOUND THE SOLUTION MET CHEMICAL SPECIFICATIONS; PRESERVATIVE AND MICROBIOLOGY TESTING IS IN PROGRESS. BASED ON ALL AVAILABLE INFO, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT REPORTED AFTER RINSING AND STORING LENSES OVERNIGHT IN SOLUTION, THE LENSES APPEARED MISSHAPEN AND UPON INSERTION BOTH EYES BEGAN TO BURN. PT WHO IS AN EMERGENCY ROOM NURSE SELF DIAGNOSED AS HAVING A CHEMICAL BURN AND SELF TREATED WITH OVER THE COUNTER ANTIHISTAMINE DROPS AND ANTI-INFLAMMATORY DROPS. PT ALSO EXPERIENCED LIGHT SENSITIVITY AND DECIDED TO SEEK MEDICAL ATTENTION. MEDICAL DOCUMENTATION REC'D NOTED PT HAD CHEMICAL KERATITIS AND IRITIS IN BOTH EYES. DOCTOR CANNOT DETERMINE THE EXACT CAUSE OF THE EVENT. PT WAS TREATED WITH BLEPHAMIDE AND CONDITION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129553 RENU FRESH MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB GJ2005

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention ACUVUE OASYS CONTACT LENSES