BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS DAILIES VISITINT AQUA RELEASE

    MDR report key: 3131088 · Received May 23, 2013

    Report

    Report Number
    1065835-2013-00007
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    February 7, 2013
    Report Date
    April 23, 2013
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    MVN
    PMA / PMN Number
    K050065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVAL. 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 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 ORIGINALLY REPORTED ON (B)(6) 2013 BY THE PT THAT A CONTACT LENS TORE DURING WEAR. THE PT TRIED TO REMOVE THE LENS AND REMOVED PART OF THE LENS. SHE VISITED THE EYE CARE PROFESSIONAL (ECP) WHO REMOVED THE REMAINING LENS FROM HER EYE. IT IS NOTED THAT THE PT RECOVERED. ADD'L INFO RECEIVED ON (B)(6) 2013 STATED THAT THE ECP CONFIRMED THAT THE PT'S EYE HAD RECOVERED AND SHE HAD RESUMED LENS WEAR WITHOUT ANY ISSUES. ADD'L INFO WAS RECEIVED ON (B)(6) 2013 FROM THE PT'S LAWYER WHICH SUMMARIZES THE EVENTS AS FOLLOWS: ON (B)(6) 2013. THE LENS WAS TORN IN THE EYE DURING REMOVAL. ON (B)(6) 2013, THE PT EXPERIENCED A COMFORT ISSUE UNDER THE UPPER EYELID. ON (B)(6) 2013, THE PT WENT TO THE HOSPITAL, HOWEVER, THE ECP COULD NOT FIND A FOREIGN BODY ON THE EYE. THE SYMPTOMS GOT WORSE DURING THE DAY AND THE PT VISITED ANOTHER ECP WHO COULD ALSO NOT FIND A FOREIGN BODY ON THE EYE, BUT PRESCRIBED FLOXAL ANTIBIOTIC DROPS AND REWETTING DROPS FOR TWO DAYS. WHILE USING THE MEDICATION THE SYMPTOMS GOT BETTER, BUT ONCE SHE STOPPED THE SYMPTOMS GOT WORSE. ON (B)(6) 2013, THE PT WENT TO ANOTHER ECP WHO COULD NOT FIND A FOREIGN BODY ON THE EYE. FLUO NEGATIVE; NO EROSION; SWELLING OF THE UPPER EYE LID (VISUAL ACUITY 1.0). THE PT WAS PRESCRIBED THE FOLLOWING MEDICATION: DEXA OPHTHAL SINE 6 TIMES A DAY/BEPANTHEN EDO EYE DROPS 4 TIMES A DAY AND AZYTER EYE DROPS 2 TIMES A DAY FOR 3 DAYS. ON (B)(6) 2013, ON THE FOLLOW-UP VISIT, THE PT VISUAL ACUITY WAS AT 0.8 AND A SLOW DECLINE OF THE SWOLLEN EYE LIDS. ON (B)(6) 2013 ON THE NEXT DAY F/U VISIT, THERE WAS A CLEAR DECLINE OF THE SWOLLEN EYE LIDS AND THE FOLLOWING MEDICATION PRESCRIBED: DEXA OPHTHAL SINE 6 TIMES A DAY AND REWETTING DROPS. ADDITIONAL INFO WAS RECEIVED FROM THE TRANSLATED LETTER FROM THE LAWYER AND THE EPICRISIS REPORT ON (B)(6) 2013 WHICH STATES THE FOLLOWING: THE TREATMENT PERIOD FOR THIS PT WAS (B)(6) 2013 AND THE DIAGNOSIS IS CONSECUTIVE BLEPHAROCONJUNCTIVITIS WITH ACCOMPANYING LYMPHADENITIS AFTER A PERSISTING SOFT CONTACT LENS FRAGMENT ANAMNESIS AFTER ABOUT 2 WEEKS ON THE EYEBALL. THE PT PLACED THE SOFT CONTACT LENSES IN THE RIGHT AND LEFT EYE FOR DAILY USE ON (B)(6) 2013 AND UPON REMOVAL IN THE EVENING (WITH NO IRRITATION OF ANTERIOR EYE SEGMENTS), BREAKAGE OF THE RIGHT CONTACT LENS AND ONLY PARTIAL REMOVAL. FEELING OF FOREIGN BODY IN THE EYE. THE SYMPTOMS UNDER THE UPPER EYELID WORSENED OVER THE NEXT DAY, APPLICATION OF ARTIFICIAL TEARS WITHOUT RELIEF. ON (B)(6) 2013, SHE VISITED THE HOSPITAL AND NO FOREIGN BODY WAS DETECTED. AT THIS POINT IN TIME, MECHANICAL CLEANING OF THE UPPER FORNIX WITH A COTTON SWAB WAS PERFORMED BY THE COLLEAGUE. FURTHER WORSENING OF SYMPTOMS DURING THE DAY AND RENEWED VISIT TO THE HOSPITAL. AGAIN, NO FOREIGN BODY WAS FOUND AFTER INSPECTION AND ALSO AFTER EVERSION OF THE UPPER LID. PRESCRIBED FLOXAL FOR 2 DAYS AS A CONTINUATION OF TREATMENT, AS WELL AS ARTIFICIAL TEARS. ACCORDING TO THE PT, THERE WAS SOME RELIEF FROM SYMPTOMS OF THE COMPLAINT, HOWEVER, AFTER DISCONTINUATION DURING THE COURSE OF THE FOLLOWING WEEK THERE WAS A PERMANENT FEELING OF HAVING A FOREIGN BODY, SUBTARSAL RIGHT, WHICH CONTINUED UNTIL (B)(6) 2013, AND WORSENED AGAIN DUE TO SWELLING OF THE UPPER LID IN THE MORNING. ON (B)(6) 2013, THE PT'S VISUAL ACUITY WAS 1.00. THERE WAS SWELLING OF THE UPPER LID, CLOSE TO THE LID EDGE. NO MEIBOMITIS. CORNEA SMOOTH, CLEAR AND REFLECTIVE WITHOUT EROSIONS. FLUO NEGATIVE. MASSIVE SWELLING OF CONJUNCTIVA ALSO BULBAR IN THE CRANIAL REGION. EVERSION OF THE LID, PETECHIAL BLEEDING ON THE TARSUS AS WELL AS A TEMPORAL BULBAR HYPOSPHAGMA, TEAR DUCT BLAND, MOTILITY IN ALL 9 VISUAL DIRECTIONS FREE. NO DIRECT DETECTION OF ANY FOREIGN BODIES. PUPILLOMOTOR FUNCTION FREE. LENS CRYSTALLINE CLEAR AND LOCAL. VITREOUS CAVITY CLEAN. A MICROBIOLOGICAL SMEAR WAS TAKEN AND IT WAS FOUND THAT THE BACTERIA WAS NEGATIVE, NO DETECTION OF MOULDS OR HYPHOMYCETES. INITIAL THERAPY USED: DEXA OPHTHAL SINE 6 X PER DAY IN COMBINATION WITH BEPAHTHEN EDO EYE DROPS 4 X PER DAY AS WELL AS CHANGEOVER FOR A SHORT-TERM ANTIBIOSIS WITH AZYTER EYE DROPS 3 DAYS 2 X PER DAY. FOLLOW-UP ON (B)(6) 2013. ON (B)(6) 2013, THE PT APPEARED WITH WORSENING OF THE ANTERIOR EYE SEGMENT FINDING ON THE RIGHT. THE SIGHT OF THE PT WAS 0.63 WITH BEST CORRECTION, LEFT EYE WAS 1.0. UPPER LID SWELLING PROGRESSIVE, NOW ALSO SWELLING IN THE LOWER LID AS WELL AS LYMPHADENITIS PRE-AURICULAR, NO FEBRILE TEMPERATURE, NO CATARRH OF THE UPPER RESPIRATORY TRACT. THERE WAS AN INCREASE OF THE CONJUNCTIVA CHEMOSIS TO THE CORNEAL LIMBUS, FURTHER SMALL HYPOSPHAGMAGATA SITUATED SUBCONJUNCTIVAL AND EPISCLERAL, PARTLY VISIBLE. IN THE LOWER FORNIX. AFTER THE UPPER EYELID WAS INSPECTED AGAIN, 1/3 OF THE SOFT CONTACT LENS WHICH HAD BEEN PERSISTING FOR WEEKS COULD BE SEEN AS A FOREIGN BODY FAR SUPERIOTEMPORAL WITH CONTACT TO THE TEAR DUCT, WHICH WAS SWOLLEN AND DOUGHY. THE LENS WAS REMOVED. CORNEAL SURFACE STILL SMOOTH AND CLEAR, THE EYEBALL IS STILL INTRAOCULAR NON-IRRITATED, THE INTRAOCULAR PRESSURE CONDITIONS ARE NORMOTENSIVE AFTER REPEATED CHECKING. THE PT WAS PRESCRIBED HYDROCORTISONE EYE OINTMENT IN CONNECTION WITH LOCAL ANTIBIOTIC EYE OINTMENT (FLOXAL), AND A CLOSED BANDAGE FOR 24 HOURS. ORAL ANTIBIOSIS WITH DOXYCYCLINE 100 MG 1 X 1 PER DAY. F/U ON (B)(6) 2013, THE RIGHT EYE SIGHT HAD INCREASED TO 0.8, ONLY SLIGHTLY MODERATE REDUCTION IN THE SWELLING OF THE UPPER LID AND LOWER LID AREA, STILL MASSIVE CONJUNCTIVA CHEMOSIS, PARTIALLY WITH A PREVAILING HEMATOGENIC SECRETION. RENEWED CLOSED BANDAGE IN COMBINATION WITH STEROIDS AND A LOCAL ANTIBIOTIC IN OINTMENT FORM FOR 24 HOURS. F/U ON (B)(6) 2013, THE RIGHT EYE NOW HAD A CLEAR REDUCTION OF THE LID SWELLING. PREVAILING CONJUNCTIVAL CHEMOSIS OF THE EYEBALL, HOWEVER, INTRA-CONJUNCTIVAL HEMORRHAGIC RESORPTION. EXTENSIVE SPREADING OF FLECK-SHAPED EPISCLERAL BLEEDING. CONJUNCTIVAL CHEMOSIS IN THE TEMPORAL UPPER ANTERIOR QUADRANT WITH A PUNCTUM MAXIMUM. STILL NO CORNEAL ALTERATION. REGULAR INTRAOCULAR PRESSURE. NO INTRAOCULAR IRRITATION OF THE EYEBALL. DISCONTINUATION OF BANDAGING. RENEWED CHANGEOVER TO LOCAL STEROID THERAPY WITH DEXA OPHTHAL SINCE 6X PER DAY IN COMBINATION WITH A PURELY SOOTHING ARTIFICIAL TEARS TO REDUCE SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229503 FOCUS DAILIES VISITINT AQUA RELEASE LENS, CONTACT (DISPOSABLE) MVN CIBA VISION CORPORATION A0178305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other