BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE STERILE 12 FL. OZ SALINE SOLUTION

    MDR report key: 379052 · Received February 21, 2002

    Report

    Report Number
    MW1024173
    Event Type
    Injury
    Date Received
    February 21, 2002
    Date of Event
    February 21, 2002
    Report Date
    February 21, 2002
    Manufacturer
    SIGHT SAVERS INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EARLY IN THE MORNING PT INSERTED CONTACT LENSES INTO THEIR EYES, RINSING THEM WITH A NEWLY OPENED 12 OZ. BOTTLE OF EQUATE STERILE SALINE SOLUTION PURCHASED AT STORE. PT EXPERIENCED SOME BURNING SENSATION, BUT WITHIN 45 MINUTES, THEY SUDDENLY EXPERIENCED A SIGNIFICANT BLURRING OF VISION, SOMEWHAT LIKE HAVING A DENSE CURTAIN OF FOG OVER THEIR EYES, AND A TERRIBLE BURNING SENSATION. AFTER REMOVING THEIR CONTACTS, THE PROBLEM CONTINUED. PT WENT TO THEIR EYE DR WITHIN 3 HOURS. PT WAS HAVING A SEVERE CHEMICAL REACTION, MOST LIKELY FROM THE SALINE. THE RESULT WAS A SEVERE IRRITATION OF THE CORNEA WHICH COULD HAVE BEEN WORSE HAD PT CONTINUED USING THE PRODUCT. PT LATER FOUND OUT THAT MANY CASES OF THESE PROBLEMS HAD BEEN REPORTED TO STORE. ANOTHER LOCAL EYE SURGEON REPORTEDLY HAD A PT WHO EXPERIENCED EYE ULCERS FROM THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUATE STERILE 12 FL. OZ SALINE SOLUTION * LPN SIGHT SAVERS INC. * 2004-12 GM 1009

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention