BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES VISITINT AQUACOMFORT PLUS

    MDR report key: 4212979 · Received October 24, 2014

    Report

    Report Number
    1065835-2014-00018
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    August 23, 2014
    Report Date
    September 10, 2014
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    LPL
    PMA / PMN Number
    K072777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD AND STERILIZATION RECORD FOR THIS LOT HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. UNOPENED PRODUCT FROM THE SAME LOT WAS RETURNED AND FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO NONCONFORMITY OR DEVIATIONS DURING THE MFG PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2014 THAT THE PT EXPERIENCED A LENS THAT WAS TORN DURING WEAR. THE PT VISITED THE HOSPITAL BECAUSE SHE FELT THAT THERE WAS STILL A PIECE OF THE LENS IN HER EYE. THE HOSPITAL CONFIRMED THAT THEY REMOVED SOMETHING FROM THE PT'S EYE, BUT COULD NOT CONFIRM IF IT WAS A PIECE OF THE LENS, BECAUSE IT WAS NOT RETAINED. THE PT STATED THAT SHE HAD A SCRATCHED CORNEA AND WAS GIVEN STEROID EYE DROPS. ADDITIONAL INFO RECEIVED FROM THE ECP ON (B)(6) 2014 STATING THAT THE EVENT OCCURRED ON (B)(6) 2014 AND INVOLVED THE RIGHT EYE. THE PT HAD FOUR VISITS TO THE HOSPITAL. THE PT HAD A PIECE OF CONTACT LENS SCRAPED OUT OF THE EYE AT THE HOSPITAL. SHE EXPERIENCED SEVERE PAIN, AND SEVERE REDNESS. IT IS UNK IF THERE WAS ANY ANTERIOR CHAMBER REACTION OR DISCHARGE INVOLVED. IT WAS NOTED THAT THERE WAS A CORNEAL ULCER OF 1.5MM IN SIZE WHICH WAS CENTRALLY LOCATED AND IT WAS UNK IF THERE WERE ANY INFILTRATES. THE PT HAD SEVERE CORNEAL STAINING AND THERE WAS PERMANENT SCARRING NOTED. THE PT WAS GIVEN 3X ANTIBIOTICS AND THE DOSAGE WAS EVERY HOUR. THE PT WAS STILL BEING SEEN BY THE DOCTOR AT THE HOSPITAL AT THE TIME THIS INFO WAS RECEIVED AND LENS WEAR HAD NOT RESUMED. IT WAS UNK IF THE EVENT HAD RESOLVED YET. THE BEST CORRECTED VISUAL ACUITY PRIOR TO THE SYMPTOMS WAS RE 6/5-2 AND THE BEST CORRECTED VISUAL ACUITY AFTER THE SYMPTOMS WAS RE 6/9-1. ADDITIONAL INFO WAS RECEIVED FROM THE PT ON (B)(6) 2014 VIA LETTER DESCRIBING THE EVENT IN DETAIL. THE PT AWOKE WITH A SORE EYE ON (B)(6) 2014, SO SHE DID NOT INSERT CONTACT LENSES. BY LATE EVENING THE EYE WAS SORE, BLOOD SHOT, RED, UNCOMFORTABLE AND WATERY. PT WENT TO THE HOSPITAL IN THE EARLY MORNING ON (B)(6) 2014 AND WAS STRUGGLING TO OPEN THE EYE AND IT WAS VERY LIGHT SENSITIVE. AT THE HOSPITAL, THE PT WAS EXAMINED AND TOLD SHE HAD CONJUNCTIVITIS. SHE WAS GIVEN EXOCIN DROPS TO PUT IN THE EYE 4-6 TIMES A DAY. A FEW DAYS LATER THE EYE SEEMED TO BE GETTING BETTER WITH THE DROPS. HOWEVER, BY (B)(6) 2014, THE PT AWOKE WITH ALL THE ORIGINAL SYMPTOMS, AND EVEN FEELING WORSE. THE PT WENT TO A DIFFERENT HOSPITAL AND WAS INFORMED THAT SHE HAD A "REALLY BAD INFECTION" IN THE RIGHT EYE AND TO CONTINUE WITH THE EXOCIN DROPS EVERY HOUR AND TO RETURN THE NEXT DAY FOR FOLLOW UP. THE PT RETURNED TO THE HOSPITAL ON (B)(6) 2014 AND WAS TOLD THAT THE INFECTION WAS STILL ONGOING AND THEY FOUND A TINY PIECE OF THE CONTACT LENS THAT HAD BROKEN OFF IN THE EYE. THEY REMOVED THE LENS FRAGMENT WITH A NEEDLE. THE PT WAS INFORMED TO CONTINUE WITH THE EXOCIN DROPS EVERY TWO HOURS AND TO RETURN FOR A FOLLOW UP ON (B)(6) 2014. THE PT RETURNED TO THE HOSPITAL ON (B)(6) 2014 AND WAS INFORMED THAT THE BROKEN PIECE OF THE CONTACT LENS IN THE EYE HAD CAUSED DAMAGE TO THE EYE AND HAD LEFT A SCAR ON THE EYE. THE INFECTION WAS STILL PRESENT AND THEY PRESCRIBED THE PT MAXIDEX AND CARMIZE EYE DROPS TO USE, AS WELL AS TO CONTINUE WITH EXOCIN DROPS. THE PT RETURNED TO THE HOSPITAL ON (B)(6) 2014 AND WAS INFORMED THAT THE INFECTION WAS STILL PRESENT AND TO CONTINUE WITH MAXIDEX, EXOCIN, AND CARMIZE EYE DROPS TO USE 4-6 TIMES PER DAY FOR A WEEK AND THEN RETURN FOR A FOLLOW UP. THE PT RETURNED TO THE HOSPITAL ON (B)(6) 2014 WHERE THEY INFORMED THE PT TO CONTINUE WITH MAXIDEX AND CARMIZE EYE DROPS FOR THE NEXT THREE WEEKS AND THE PT WAS DISCHARGED FROM CARE. THE PT WAS INFORMED TO USE MAXIDEX 3 TIMES A DAY AND CARMIZE IF NEEDED FOR THE FIRST WEEK. FOR THE SECOND WEEK, SHE WAS TOLD TO USE MAXIDEX 2 TIMES A DAY AND CARMIZE IF NEEDED. FOR THE THIRD WEEK SHE WAS TOLD TO USE MAXIDEX ONCE A DAY AND CARMIZE IF NEEDED. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678899 DAILIES VISITINT AQUACOMFORT PLUS LENS, CONTACT (DISPOSABLE) LPL CIBA VISION CORPORATION A0385908

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other