BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU FRESH MULTI-PURPOSE SOLUTION

    MDR report key: 4255568 · Received November 10, 2014

    Report

    Report Number
    1313525-2014-00012
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE RESULTS OF THE CHEMICAL TESTING PERFORMED WERE CONSISTENT WITH SHELF LIFE LIMITS. BASED ON ALL INFO, NO CASUAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A (B)(6) FEMALE EXPERIENCED BURNING, PAIN, EDEMA AND BLURRED VISION RESULTING IN A VISIT TO EMERGENCY CARE AFTER USE OF PRODUCT. ACCORDING TO THE PATIENT, THE OPHTHALMOLOGIST DIAGNOSED BILATERAL CORNEO-CONJUNCTIVAL BURNING MORE SEVERE ON THE RIGHT EYE. OPHTHALMOLOGIST TREATED PATIENT AND ADMINISTERED A CORTICOSTEROID TREATED PATIENT AND ADMINISTERED A CORTICOSTEROID INJECTION IN RIGHT EYE CONJUNCTIVA. DOCTOR INFORMED PATIENT THAT THE CORNEAL BURN WAS A GRADE 3 ON THE RIGHT EYE AND GRADE 1 IN THE LEFT EYE. AT FOLLOW UP VISIT 2 DAYS LATER, PATIENT'S DISTANCE CORRECTED VISUAL ACUITY IN THE LEFT EYE WAS 08/10; THE RIGHT EYE DISTANCE CORRECTED VISUAL ACUITY WAS 3/10. PATIENT HAD ANOTHER F/U VISIT 4 DAYS LATER, DISTANCE CORRECTED VISUAL ACUITY IN THE LEFT EYE WAS 08/10 AND THE RIGHT EYE DISTANCE CORRECTED VISUAL ACUITY SHOWED LITTLE IMPROVEMENT. PATIENT HAD CORNEAL ULCERS AND WAS INSTRUCTED TO CONTINUE TREATMENT FOR 5 WEEKS. TREATING DOCTOR WAS CONTACTED AND CONFIRMED THERE WAS NO INFECTION, NO CULTURES WERE PERFORMED. PATIENT'S FUNDUS EXAMINATION IS FINE; CONDITION HAS IMPROVED AND A FOLLOW UP VISIT IS SCHEDULED IN ONE MONTH. WE ARE AWAITING ADDITIONAL INFO FROM THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723244 RENU FRESH MULTI-PURPOSE SOLUTION CONTACT LENS MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB, INC. BE096.2

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention