BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUIFY MULTIPURPOSE SOLUTION

    MDR report key: 1062887 · Received June 18, 2008

    Report

    Report Number
    8020392-2008-00005
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    April 7, 2008
    Report Date
    May 21, 2008
    Manufacturer
    CIBA VISION CANADA, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS REVIEWED BY THE CIBA VISION MEDICAL MONITOR WITH THE FOLLOWING CONCLUSION: "THIS CASE IS CONSIDERED AS A NON-INFECTIOUS CORNEAL ULCER, LOCATED CENTRAL CORNEA." NO PROD WAS RETURNED FOR INVESTIGATION. A MFG INVESTIGATION OF THE REPORTED LOT NUMBER IS UNDERWAY. IF ANY ABNORMALITY IS FOUND, A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT A FEMALE PT EXPERIENCED A RIGHT EYE CORNEAL ABSCESS/ULCER ASSOCIATED WITH USE OF AQUIFY MULTIPURPOSE CONTACT LENS SOLUTION & WEAR OF "OPHTHALMIC 55" (MFG UNK) CONTACT LENS. ULCER WAS LOCATED INFERIOR PARA-CENTRAL CORNEA. INITIAL TREATMENT (UNSPECIFIED) WAS PROVIDED BY HOSP BASED PHYSICIAN, THEN FOLLOWED BY REPORTING ECP. MILD PAIN, NO ANTERIOR CHAMBER RESPONSE, AND A NEGATIVE CULTURE FOR THE LENS, CASE, AND OPENED SOLUTION (ALTHOUGH THERE WAS NO REPORT OF A CORNEAL CULTURE). EVENT RESOLVED WITH NO REDUCTION IN VISUAL ACUITY & NO SCAR. PRE-EVENT ACUITY REPORTED AS 10/10, POST-EVENT 10/10, RIGHT EYE. REQUEST HAS BEEN MADE FOR RETURN OF LENS CARE SOLUTION FOR FURTHER INVESTIGATION. NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUIFY MULTIPURPOSE SOLUTION CONTACT LENS SOLUTION LPN CIBA VISION CANADA, INC. NA 74766

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention NONE REPORTED.