BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1

    MDR report key: 3940577 · Received June 18, 2014

    Report

    Report Number
    9610813-2014-00014
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 23, 2014
    Manufacturer
    CIBA VISION GMBH
    Product Code
    MVN
    PMA / PMN Number
    K113168
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT FROM THE SAME LOT NUMBER WAS RETURNED FOR EVALUATION AND FOUND TO MEET SPECIFICATIONS. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EYE CARE PROFESSIONAL (ECP) THAT A PATIENT DEVELOPED A PRESUMED PSEUDOMONAS ULCER ON HER RIGHT EYE A COUPLE WEEKS AGO. THE PATIENT WOULD WEAR A PAIR OF LENSES OVERNIGHT AND THEN REPLACE THEM IN THE MORNING WITH A NEW PAIR. THE PATIENT HAS MISSED 3 WEEKS OF WORK THUS FAR AND "WON'T EVER HAVE GREAT VISION IN THAT EYE AGAIN". ADDITIONAL INFORMATION RECEIVED FROM THE ECP (WHO IS ALSO THE PATIENT'S HUSBAND) ON (B)(6) 2014 STATING THAT THE PATIENT'S RIGHT EYE BEGAN BOTHERING HER ON THURSDAY ((B)(6) 2014). THE PATIENT WAS SEEN BY THE TREATING ECP ON FRIDAY MORNING ((B)(6) 2014) AND SHE WAS DIAGNOSED WITH AN ULCER IN HER RIGHT EYE AND SHE WAS STARTED ON BESIVANCE FOUR TIMES A DAY. THE PATIENT EXPERIENCED A LOT MORE PAIN THAT NIGHT AND WAS VERY UNCOMFORTABLE THE NEXT MORNING. THE TREATING ECP, AS WELL AS ANOTHER ECP COLLEAGUE LOOKED AT IT AGAIN THAT DAY AND NOTICED THAT THE ULCER WAS WORSE AND HAD AN UNUSUAL APPEARANCE TO IT. THE PATIENT WAS THEN STARTED ON A CYCLOPLEGIC AND THE ECP CONTACTED THE ON-CALL OPHTHALMOLOGIST, WHO AGREED THAT THE ULCER LOOKED ODD AND PRESCRIBED FORTIFIED VANCOMYCIN AND FORTIFIED TOBRAMYCIN - ALTERING EACH EVERY 30 MINUTES. THE OPHTHALMOLOGIST ALSO PRESCRIBED THE PATIENT TO USE AN ORAL CIPRO AND ORAL VALTREX. HE ALSO PRESCRIBED PERCOCET AND ZOFRAN DUE TO HER PAIN AND NAUSEA. THE PATIENT'S VISION AT THAT POINT WAS STILL CORRECTABLE TO 20/25. THE NEXT DAY (SUNDAY, (B)(6) 2014) THE INFILTRATE BEGAN MOVING UP TO THE PUPIL. THE PATIENT DROPPED HER VISUAL ACUITY FROM 20/30 THAT MORNING TO HAND MOTION THAT EVENING. THE NEXT DAY ((B)(6) 2014) THE PATIENT SAW THE OPHTHALMOLOGIST AGAIN, AND ALSO SAW A MEDICAL DOCTOR. VARIOUS TREATMENT OPTIONS WERE DISCUSSED, AND IT WAS DECIDED FOR THE PATIENT TO SEE A CORNEAL SPECIALIST. THE PATIENT'S VISION WAS STILL VERY POOR AND SHE HAD DEVELOPED A HYPOPYON. THE CORNEAL SPECIALIST WAS SEEN LATER THAT DAY. HE DID A SCRAPE CULTURE, BUT THOUGHT THAT THE TREATMENT WAS BEGINNING TO WORK. HE DISCONTINUED THE CIPRO, BUT ADDED AN ORAL ANTI-FUNGAL. HE SAW THE PATIENT A COUPLE OF MORE TIMES THAT WEEK, BUT THE TREATMENT WAS THE SAME. THE PATIENT BEGAN TO GET A LITTLE BETTER THE FOLLOWING WEEK. THE ULCER FINALLY RE-EPITHELIALIZED AT THE END OF THE NEXT WEEK ((B)(6) 2014). THE PATIENT'S PAIN SUBSIDED, BUT SHE WAS STILL VERY IRRITATED FROM THE FORTIFIED ANTIBIOTICS. THOSE WERE TAPERED DOWN QUITE A BIT THAT WEEK. THE PATIENT ALSO OBTAINED A SECOND OPINION FROM ANOTHER CORNEAL SPECIALIST. THE PATIENT SAW THE FIRST CORNEAL SPECIALIST AGAIN ON (B)(6) 2014. A STEROID HAD BEEN ADDED TO THE PRESCRIPTION AT THAT POINT (PRED FORTE TWICE A DAY) AND TAPERED OFF THE ANTIBIOTICS. CURRENTLY, THE PATIENT HAS APPROXIMATELY 20/200 ACUITY AND PINHOLES TO APPROXIMATELY 20/70. THE ORIGINAL TREATING ECP IS WAITING ANOTHER COUPLE OF WEEKS BEFORE FITTING HER IN A GAS PERMEABLE LENS. IT IS NOTED THAT THERE IS STILL A DECENT CHANCE THAT SHE WILL NEED A CORNEAL TRANSPLANT, AND SHE WILL DEPEND ON HOW GOOD THE ACUITY IS WITH THE GAS PERMEABLE LENSES. THE PATIENT HAS TO WAIT SIX (6) MONTHS BEFORE SHE CAN CONSIDER THAT OPTION. ANOTHER FOLLOW UP WITH THE FIRST CORNEAL SPECIALIST WILL BE DUE AGAIN IN ABOUT A MONTH. THE PATIENT HAS MISSED 3 FULL WEEKS OF WORK. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ECP ON (B)(6) 2014 STATING THAT THE DATE OF THE EVENT WAS (B)(6) 2014 AND INVOLVED THE RIGHT EYE, DIAGNOSIS OF PRESUMED PSEUDOMONAS ULCER. THE PATIENT EXPERIENCED SEVERE PAIN/DISCOMFORT, SEVERE REDNESS, WATERY DISCHARGE, AND SEVERE ANTERIOR CHAMBER REACTION. THE ULCER WAS CENTRALLY LOCATED 4MM (H) X5.5MM IN SIZE WITH ONE CENTRAL INFILTRATE 4MM (H) X5.5MM IN SIZE. THE PATIENT HAD MODERATE CORNEAL STAINING COVERING LESS THAN 50% OF THE CORNEA. PERMANENT SCARRING WAS NOTED. THE PATIENT WAS PRESCRIBED FORTIFIED VANCOMYCIN AND FORTIFIED TOBRAMYCIN. THE EVENT HAS NOT RESOLVED YET, THE PATIENT HAS NOT RESUMED LENS WEAR AND THE PATIENT HAS FOLLOW-UP SCHEDULED. THE PATIENT HAS A CENTRAL LOCATED SCAR AND PERMANENT VISION LOSS AND IRREGULAR K. THE PATIENT'S BEST CORRECT VISUAL ACUITY PRIOR TO THE EVENT WAS 20/20, AND SO FAR, THE BEST CORRECTED VISUAL ACUITY IS APPROXIMATELY 20/70. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357762 DAILIES TOTAL 1 LENS, CONTACT (DISPOSABLE) MVN CIBA VISION GMBH N1117003

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other