BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES VISITINT AQUACOMFORT PLUS

    MDR report key: 2960333 · Received February 8, 2013

    Report

    Report Number
    1065835-2013-00001
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    May 14, 2012
    Report Date
    January 17, 2013
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    LPL
    PMA / PMN Number
    K072777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE LOT NUMBER IS UNKNOWN. SINCE THE PRODUCT IS MANUFACTURED AT MULTIPLE LOCATIONS, IT IS UNKNOWN WHICH MANUFACTURING SITE WAS INVOLVED. A MANUFACTURING SITE WAS RANDOMLY SELECTED. BOTH MANUFACTURING SITES PERFORMED TREND RELATED INVESTIGATIONS. NO TRENDS COULD BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED.(B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED BY EYE CARE PROFESSIONAL (ECP) THAT A PT IS BEING TREATED BY THE SPECIALIST #2 ECP FOR ACANTHAMOEBA. IT IS NOTED THAT THE PT IS A SWIMMER; HOWEVER, HER PARENTS HAVE STATED THAT SHE IS A COMPLIANT CONTACT LENS WEARER AND DOES NOT SLEEP IN HER LENSES. RECEIVED ADDITIONAL INFORMATION FROM THE FIRST TREATING ECP ON (B)(6) 2013, WHICH STATES THE PT HAS WORN OTHER CONTACT LENS PRODUCTS SINCE (B)(6) 2011 AND HAS NEVER EXPERIENCED ANY ISSUES. THE PT WAS SEEN BY THE FIRST TREATING ECP FOR AN IRRITATED RIGHT EYE IN (B)(6) 2012, WHEN THE IRRITATION DID NOT CLEAR UP WITHIN 24 HOURS (THE EYE HAD BEEN BOTHERING HER FOR A WEEK BY THAT TIME), THE FIRST TREATING ECP REFERRED THE PT TO SPECIALIST #1. THE FIRST TREATING ECP AND SPECIALIST #1 BOTH THOUGHT THAT IT LOOKED TO BE VIRAL AND SPECIALIST #1 WAS TREATING IT WITH UNSPECIFIED VIRAL MEDICATION. WHEN THERE WAS NO IMPROVEMENT, THE PT WAS REFERRED TO SPECIALIST #2, WHO DIAGNOSED ACANTHAMOEBA. A CULTURE WAS PERFORMED AND IT WAS CONFIRMED TO BE ACANTHAMOEBA. THE FIRST TREATING ECP NOTED THAT THE SPECIALIST (#1 AND #2) WERE TREATING AN ULCERATION OF THE CORNEA. THE EYE HAS NOT RESOLVED AND THE SPECIALIST #2 IS RECOMMENDING A CORNEAL TRANSPLANT, BUT IT WAS STATED THAT THE PT DOES NOT WANT TO DO THIS. THE FIRST TREATING ECP NOTED THAT THE PT WAS SWIMMING AND/OR EXERCISING IN GYM CLASS ABOUT A MONTH BEFORE THE IRRITATION STARTED. THE PT IS ALSO A CROSS COUNTRY RUNNER AND IS OUTSIDE A LOT. HE ALSO MENTIONED THAT THE PT USES WELL WATER AT HOME. HE THOUGHT THAT THESE COULD POSSIBLY BE CONTRIBUTING FACTORS. RECEIVED THE COMPLETED ADVERSE EVENT (AE) FORM REGARDING THE EVENT FROM SPECIALIST #2 ON (B)(6) 2013 WHICH STATES THAT THE PT FIRST PRESENTED TO SPECIALIST #2 ON (B)(6) 2012 AND THE PT HAD BEEN OUT OF CONTACT LENSES FOR APPROXIMATELY 2 MONTHS WHEN THE PT WAS SEEN. THE RIGHT EYE IS INVOLVED, AND THE PT HAD NO PRE-EXISTING CONDITIONS. A CULTURE WAS PERFORMED AND WAS FOUND POSITIVE FOR ACANTHAMOEBA ORGANISM. THE PT HAD MILD REDNESS, NO DISCHARGE AND NO ANTERIOR CHAMBER REACTION. THERE WAS NO ULCER, BUT INFILTRATES WERE PRESENT; THE PT HAD SEVERAL RAISED EPITHELIAL DOT-LIKE LESIONS ON THE CENTRAL CORNEA. THERE WAS NO CORNEAL STAINING AND PERMANENT SCARRING IS NOTED. TREATMENT PRESCRIBED IS PREDNISOLONE ACETATE, POLYHEXAMETHYLENE BIGUANIDE (PHMB), VORICONAZOLE, DESOMEDINE 0.1% - ALL MEDICATION TAKEN SIX TIMES PER DAY. THE EVENT HAS NOT RESOLVED. THE PT IS CURRENTLY BEING SEEN FOR FOLLOW UP APPOINTMENTS EVERY 2 WEEKS. THE PT HAS NOT RESUMED LENS WEAR, AS THE ISSUE HAS NOT RESOLVED COMPLETELY. RECEIVED FOLLOW UP INFORMATION ON (B)(6) 2013, WHICH STATES THAT SPECIALIST #2 SAW THE PT ON (B)(6) 2013 AND HER ISSUE IS RESOLVING BUT NOT COMPLETELY RESOLVED YET. IT WAS STATED THAT THE PT IS CURRENTLY TAKING HER MEDICATION AND HER MEDICATION AND IS BEING SEEN BY SPECIALIST #2 EVERY TWO WEEKS OR SO AND MAY EVENTUALLY NEED A CORNEAL TRANSPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54100 DAILIES VISITINT AQUACOMFORT PLUS LENS, CONTACT (DISPOSABLE) LPL CIBA VISION CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other