BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES TOTAL 1 MULTIFOCAL

    MDR report key: 7583539 · Received June 8, 2018

    Report

    Report Number
    9610813-2018-00008
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    April 17, 2018
    Report Date
    August 27, 2018
    Manufacturer
    CIBA VISION GMBH
    Product Code
    LPL
    PMA / PMN Number
    K113168
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    NO CODE AVAILABLE: 3191 - LIGHT SENSITIVITY; SUPERFICIAL PUNCTATE KERATITIS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 29JUN2018 VIA FAXED MEDICAL RECORDS. ON (B)(6) 2018: THE PATIENT HAD IRRITATION IN THE LEFT EYE WHICH STARTED 5 DAYS AGO WITH MILD COLD AND UPPER RESPIRATORY INFECTION BUT NO OCULAR SYMPTOMS. SHE HAD SLEPT IN WITH CONTACT LENS AND WOKE UP WITH VERY IRRITATED EYES AND LIGHT SENSITIVITY, PROFUSELY WATERING AND COULDN'T KEEP OPEN. IT HAD CAUSED MODERATE TO SEVERE PAIN OR DISCOMFORT. THE PATIENT HAD SINUSITIS AND PROBLEMS AROUND UPPER FACE. THE PATIENT WENT TO A HEALTH CARE FACILITY THE NEXT DAY WITH EYELID SWOLLEN ALMOST SHUT BUT THERE WAS NO CORNEAL LACERATION NOR FLUSHED UP. SHE DISCONTINUE CONTACT LENS WEAR FOR TWO DAYS AND HAD AN UNSPECIFIED ANTIHISTAMINE. THE PATIENT WAS ABLE TO WEAR CONTACT LENS TO WORK BUT EXPERIENCED EYES REDNESS, IRRITATED, TEARY AND LIGHT SENSITIVITY MORE NOTICEABLE ON THE LEFT EYE. THE PATIENT WAS GIVEN AN UNSPECIFIED EYELID CLEANER, DURATION AND TREATMENT MODALITY WAS NOT PROVIDED, FOR OCULAR ROSACEA. THE PATIENT WAS ASSESSED WITH CORNEAL ULCER CENTRALLY LOCATED ON THE LEFT EYE CAUSING UNDERLYING IRITIS. THE PATIENT WAS ALSO SEEN WITH VIRAL CONJUNCTIVITIS ON THE LEFT EYE AND WITH MILD CORNEAL STAINING LESS THAN 50%. THE PATIENT WAS DIAGNOSED WITH EKC BY A DIFFERENT ECP. THE PATIENT WAS PRESCRIBED WITH MOXIFLOXACIN EVERY HOUR FOR TWO DAYS, TOBRAMYCIN OINTMENT AT NIGHT IN THE LEFT EYE AND WAS GIVEN FURTHER INSTRUCTIONS ON MEDICATIONS. SHE WAS INSTRUCTED TO RETURN FOR A FOLLOW UP CHECK ON THE CORNEA IN ONE TO TWO DAYS. ON (B)(6) 2018, THE PATIENT WAS IN FOR COMPLAINTS OF NOT FEELING BETTER SINCE STARTING MOXIFLOXACIN HOURLY EVEN DURING THE NIGHT. SHE WAS ASSESSED WITH FADING OR RESOLVING INFILTRATES VS ULCER. THE PATIENT WAS DILATED FROM MOXIFLOXACIN. THE PATIENT WAS GIVEN WITH A SAMPLE OF TOBRAMYCIN FOUR TIMES A DAY AND WAS SCHEDULED TO RETURN FOR CHECK UP. ON (B)(6) 2018, THE PATIENT WAS IN FOR A FOLLOW UP CHECK FOR HER RED EYE. THE PATIENT WAS SEEN WITH ALLEVIATING SYMPTOMS AND WAS DOING BETTER USING TOBRAMYCIN FOUR TIMES A DAY. THE PATIENT DISCONTINUED MOXIFLOXACIN. INFILTRATE VS ULCER IN LEFT EYE WAS IMPROVING. THE PATIENT WAS INSTRUCTED TO CONTINUE WITH TOBRAMYCIN FOUR TIMES A DAY AND AT'S AS NEEDED AND TO RETURN TO CLINIC IN FOUR DAYS OR SOONER IF CONDITION WORSENS. ON (B)(6) 2018, THE PATIENT CONSULTED THROUGH PHONE AS SHE WAS NOT IMPROVING WITH MOXIFLOXACIN AND WOULD LIKE TO BE REFERRED TO ANOTHER ECP. THE PATIENT NOTE THAT HER EYE WAS FEELING BETTER BUT THEN WOKE UP WITH INFLAMMATION AND ITCHINESS TO LEFT EYE WITH MUCUS USING TOBRAMYCIN FOUR TIMES A DAY WHICH SEEMED TO BE NOT WORKING. THE PATIENT WAS ADVISED TO USE THE DROPS EVERY TWO HOURS IF PREFERS AND NOTED TO SEE AN OPHTHALMOLOGIST IF SYMPTOM IS PERSISTENT FOR THREE WEEKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    AS INITIALLY REPORTED BY A FEMALE PATIENT ON (B)(6) 2018, SHE HAD A SWOLLEN SHUT EYES AS A RESULT OF WEARING THE CONTACT LENSES. MEDICAL ATTENTION WAS SOUGHT AND THE EYE CARE PROVIDER CONFIRMED THAT SHE DEVELOPED AN EPIDEMIC KERATOCONJUNCTIVITIS (EKC) IN BOTH EYES AFTER WEARING THE CONTACT LENSES. SHE WAS PRESCRIBED WITH UNSPECIFIED EYE DROPS, TREATMENT MODALITY AND DURATION WERE NOT PROVIDED. THE PATIENT BECAME ALLERGIC TO THE PRESCRIBED EYE DROPS. THE PATIENT INDICATED THAT SHE DEVELOPED A CORNEAL ULCER AS A RESULT OF EKC. THE PATIENT WENT TO AN ECP WHO CONFIRMED THAT SHE WAS ALLERGIC TO PRESERVATIVES FOUND IN THE EYE DROPS AND IN THE SOLUTION THAT THE CONTACTS CAME IN. THE PATIENT FURTHER EMPHASIZED THAT SHE WAS ALLERGIC TO B-CHLORIDE. THE PATIENT SYMPTOMS HAD ALL RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE ECP VIA EMAIL ON 03AUG2018, CONFIRMING THAT THERE WAS NO IRITIS SEEN DURING THE PATIENT'S FOLLOW UP VISITS. PER ECP, "THE PATIENT ULTIMATELY SAID SHE WAS DIAGNOSED WITH EPIDEMIC KERATOCONJUNCTIVITIS (EKP)- NOT A CORNEAL ULCER - BY ANOTHER OPHTHALMOLOGIST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424927 DAILIES TOTAL 1 MULTIFOCAL LENSES, SOFT CONTACT, DAILY WEAR LPL CIBA VISION GMBH NA N1139201

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other