BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILIES VISITINT AQUACOMFORT PLUS

    MDR report key: 4281358 · Received November 20, 2014

    Report

    Report Number
    1065835-2014-00020
    Event Type
    Injury
    Date Received
    November 20, 2014
    Report Date
    October 22, 2014
    Manufacturer
    CIBA VISION CORPORATION
    Product Code
    LPL
    PMA / PMN Number
    K072777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT FROM THE 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY AN EYE CARE PROFESSIONAL (ECP) THAT A PATIENT WAS BEING TREATED FOR A POSITIVE ACANTHAMOEBA CULTURE. REPORTED PHYSICAL EXAM FINDINGS INCLUDED A HYPOPYON, AN INFLAMMATORY ANTERIOR CHAMBER REACTION, A CENTRAL CORNEAL ULCER, AND CORNEAL INFILTRATES. IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED WITH UNSPECIFIED PAIN MEDICATIONS, AS WELL AS ANTI-FUNGAL MEDICATIONS. THE MEDICAL RECORDS REVIEWED FROM THE ECP STATE THAT THE PATIENT WAS SEEN INITIALLY ON (B)(6) 2014, AFTER PRESENTING TO AN URGENT CARE FACILITY WITH A POSSIBLE INFECTION/CORNEAL ABRASION. THE URGENT CARE FACILITY HAD PRESCRIBED TOBRAMYCIN/DEXAMETHASONE EYE DROPS; FOLLOW-UP WITH AN OPTICIAN PRIOR TO SEEING THE ECP WAS PERFORMED AS WELL, WITH THE OPTICIAN APPLYING A BANDAGE CONTACT LENS FOR ONE DAY. DURING THE VISIT WITH THE ECP ON (B)(6) 2014, IT WAS NOTED THAT THE PATIENT HAD SLEPT IN THE CONTACT LENSES AND PRESENTED WITH SEVERE/CONSTANT EYE PAIN IN THE RIGHT EYE. PHYSICAL EXAMINATION FINDINGS FROM THIS VISIT INCLUDED AN INJECTED CONJUNCTIVA OD, AN INJECTED SCLERA OD, AND AN ACR WITH CELLS/FLARE OD. A RING ULCER WITH INFILTRATES AND A WRINKLE IN DESCEMET'S MEMBRANE WERE SEEN OD AS WELL. VISUAL ACUITY (WITHOUT CORRECTION) WAS FOUND TO BE 20/200 IN THE OD AND 20/300 IN THE OS. THE PATIENT WAS DIAGNOSED WITH A RING CORNEAL ULCER AND INFILTRATES, BOTH OD. A CORNEAL CULTURE/RIGHT NOSTRIL CULTURE WAS PERFORMED AND THE PATIENT WAS GIVEN A SUBCONJUNCTIVAL INJECTION OF AN ANTIBIOTIC (WITH LIDOCAINE). THE PATIENT WAS ADVISED TO DISCONTINUE CONTACT LENS WEAR AND USE COOL COMPRESSES. THE PATIENT WAS PRESCRIBED ATROPINE EYE DROPS BID OD, ANTIBIOTIC EYE DROPS EVERY HOUR OD, LUBRICANT GEL DROPS/ ARTIFICIAL TEARS, ERYTHROMYCIN OINTMENT BID OD, AND ACYCLOVIR 200 MG BY MOUTH TID. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP IN ONE DAY. IT WAS NOTED THAT THE PATIENT WAS SEEN (B)(6) 2014 IN FOLLOW-UP, WITH SLIGHT LESSENING OF THE PAIN, USING THE MEDICATIONS PRESCRIBED AT THE PREVIOUS VISIT. THE PATIENT PRESENTED FOR A CORNEAL CHECK/FOLLOW-UP ON (B)(6) 2014 WITH PAIN, BLURRY VISION, AND LIGHT SENSITIVITY IN THE OD (SEVERE IN SEVERITY). PHYSICAL EXAMINATION FINDINGS SHOWED AN INJECTED CONJUNCTIVA OD, AN INJECTED SCLERA OD, AN ACR WITH CELLS/FLARE OD, AND A RING ULCER (MINIMALLY IMPROVED) OD. IT WAS NOTED THAT A BANDAGE CONTACT LENS WAS STILL IN PLACE AND WAS REMOVED AT THIS VISIT. VISUAL ACUITY (WITHOUT CORRECTION) IN THE OD WAS CF (COUNTING FINGERS) AND 20/100 IN THE OS. A SECONDARY DIAGNOSIS OF INFECTIOUS IRIDOCYCLITIS OD WAS GIVEN AT THAT TIME. IT WAS NOTED THAT THE PATIENT WAS IMPROVING VERY MINIMALLY. CULTURE OF THE ANTERIOR CHAMBER WAS PERFORMED, AND AN ADDITIONAL SUBCONJUNCTIVAL INJECTION OF AN ANTIBIOTIC/LIDOCAINE WAS GIVEN IN THE OD. THE PATIENT WAS INSTRUCTED TO CONTINUE THE PREVIOUSLY PRESCRIBED ANTIBIOTIC EYE DROPS AND ACYCLOVIR, AND WAS INSTRUCTED TO DECREASE THE ATROPINE TO ONCE DAILY OD. THE PATIENT WAS ALSO PROSCRIBED BACITRACIN OINTMENT BID OD, NATAMYCIN 5 PERCENT QID OD ON THE HALF HOUR, IBUPROFEN 800 MG BID, AND ACETAMINOPHEN/HYDROCODONE TABLET EVERY FOUR HOURS AS NEEDED FOR PAIN. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP IN ONE DAY. THE PATIENT WAS SEEN ON (B)(6) 2014, FEELING MUCH BETTER, BUT STILL WITH RED EYE, IRRITATION, AND DIFFICULTY KEEPING EYE OPEN (ALL SYMPTOMS OD). THE PATIENT HAD NOT BEEN ABLE TO OBTAIN THE NATAMYCIN OR BACITRACIN PRESCRIBED AT THE PREVIOUS VISIT. THE PATIENT PRESENTED FOR FOLLOW-UP ON (B)(6) 2014 WITH PAIN AND BLURRY VISION IN THE OD (MODERATE IN SEVERITY, BETTER SINCE THE DAY BEFORE). THE PATIENT HAD STOPPED THE LUBRICATING EYE GEL AND ARTIFICIAL TEARS; IT WAS NOTED THAT THE PATIENT HAD STARTED THE NATAMYCIN AND BACITRACIN. PHYSICAL EXAMINATION FINDINGS SHOWED AN ACR WITH A 1.0 MM HYPOPYON OD (STATING "SAME AS YESTERDAY"), AND AN ULCER OD (NOTING THAT THE EPITHELIUM WAS CLOSING, SMALL INFILTRATES, NO MELT SEEN, AND "QUIETER TODAY"). VISUAL ACUITY (WITHOUT CORRECTION) IN THE OD WAS HM (HAND MOTION) AND 20/100 IN THE OS. RIGHT NOSTRIL CULTURE WAS (B)(6), WITH NO GROWTH SEEN ON THE CORNEAL CULTURE AFTER TWO DAYS, WITH THE ANTERIOR CHAMBER TAP CULTURE PENDING AT THAT TIME. IT WAS NOTED THAT THE PATIENT WAS IMPROVING GRADUALLY. THE NATAMYCIN WAS INCREASED TO FIVE TIMES DAILY OD ON THE HALF HOUR AND THE BACITRACIN WAS INCREASED TO TID OD. AN ADDITIONAL SUBCONJUNCTIVAL INJECTION OF AN ANTIBIOTIC/LIDOCAINE WAS GIVEN IN THE OD. THO PATIENT WAS INSTRUCTED TO CONTINUE THE OTHER PREVIOUSLY PRESCRIBED MEDICATIONS. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP ON MONDAY, (B)(6) 2014. THE PATIENT PRESENTED FOR FOLLOW-UP ON (B)(6) 2014 WITH PAIN, BLURRY VISION, REDNESS, AND LIGHT SENSITIVITY PRESENT IN THE OD (EXTREME IN SEVERITY). THE PATIENT REMAINED ON THE PREVIOUSLY PRESCRIBED TREATMENT REGIMEN. PHYSICAL EXAMINATION FINDINGS SHOWED AN INTRAOCULAR PRESSURE OF 35MM/HG IN THE OD AND 11MM/HG IN THE OS, AN ACR WITH AN INCREASE IN HYPOPYON SIZE TO 3.0 MM OD, AN EPITHELIAL DEFECT OF 2.0 - 3.0 MM OD (APPEARING SMALLER, WITH INCREASED INFILTRATES IN DEPTH AND DIAMETER), WITH THE POSTERIOR SEGMENT OF THE OD UNABLE TO BE VIEWED. VISUAL ACUITY (WITHOUT CORRECTION) IN THE OD WAS HM (HAND MOTION) AND 20/100 IN THE OS. A SECONDARY DIAGNOSIS OF ENDOPHTHALMITIS OD WAS GIVEN, AS WELL AS INCREASED PRESSURE IN THE EYE OD, WITH THE PATIENT'S COURSE LISTED AS WORSENING. THE PATIENT WAS REFERRED URGENTLY/SAME DAY TO A CORNEAL SPECIALIST. THE PATIENT RETURNED TO THE ECP FOR FOLLOW-UP ON (B)(6) 2014. AT THAT TIME, THO PATIENT WAS EXPERIENCING BLURRY VISION WITH SLIGHTLY DECREASED PAIN (STILL EXTREME IN SEVERITY). THE PATIENT PRESENTED ON THE PREVIOUSLY PRESCRIBED ANTIBIOTIC EYE DROPS EVERY TWO HOURS, NATAMYCIN OD EVERY TWO HOURS, PHMB NOT YET STARTED (PICKING UP THAT DAY), CHLORHEXIDINE EVERY TWO HOURS, HEXAMIDINE EVERY TWO HOURS, ERYTHROMYCIN OINTMENT OD QID, VORICONAZOLE 200 MG ORAL CAPSULE BID, AND BRIMONIDINE/TIMOLOL EYE DROPS OD BID. PHYSICAL EXAMINATION FINDINGS INCLUDED A 3.0 MM HYPOPYON OD (WHICH WAS NOTED TO BE LESS) AND A CORNEAL EPITHELIAL DEFECT OF 5.0 MM. VISUAL ACUITY (WITHOUT CORRECTION) WAS NOTED AS 20/80 IN THE OS, WITH HAND MOTION IN THE OD. INTRAOCULAR PRESSURE IN THE OD WAS 26MM/HR. THE PATIENT WAS INSTRUCTED TO CONTINUE PREVIOUS MEDICATIONS, RETURN TO THE CORNEAL SPECIALIST FOR A PREVIOUSLY SCHEDULED FOLLOW-UP VISIT THE FOLLOWING MONDAY, AND RETURN TO THE ECP IN FOUR DAYS. THE PATIENT RETURNED TO THE ECP FOR FOLLOW-UP ON (B)(6) 2014. THE CHIEF COMPLAINT WAS NOTED AS BILATERAL BLURRY VISION WITH DECREASED PAIN, WITH THE PATIENT ON PREVIOUSLY PRESCRIBED ANTIBIOTIC EYE DROPS OD QID, NATAMYCIN OD QID, PHMB EVERY TWO HOURS, CHLORHEXIDINE EVERY TWO HOURS, ERYTHROMYCIN OINTMENT OD QID, VORICONAZOLE 200 MG ORAL CAPSULE BID, AND BRIMONIDINE/TIMOLOL EYE DROPS OD BID. PHYSICAL EXAMINATION FINDINGS INCLUDED AN INJECTED CONJUNCTIVA OD, INJECTED EPISCLERA OD, A 5.0 MM HYPOPYON OD (WHICH WAS NOTED TO BE IMPROVING, DOWN BY 1.0 MM), A CORNEAL EPITHELIAL DEFECT OF 5.0 MM (IMPROVING), AND NO VIEW OF THE POSTERIOR SEGMENT OF THE OD. VISUAL ACUITY WAS NOTED AS 20/100 IN THE OS (WITHOUT CORRECTION). THE PATIENT WAS INSTRUCTED TO CONTINUE THE CURRENT MEDICATIONS, WITH THE ANTIBIOTIC EYE DROPS BEING INCREASED TO 16X/DAY (EVERY WAKING HOUR) DOSING OD, WITH ACYCLOVIR 200 MG ORAL CAPSULE TID, ATROPINE 1 PERCENT OD TWO DROPS BID, AND IBUPROFEN 800 MG ORAL TABLET BID. THE PATIENT WAS TO RETURN FOR FOLLOW-UP IN TWO DAYS, OR SOONER IF THERE WAS AN INCREASE IN PAIN. IT WAS NOTED THAT A WATER SAMPLE WAS TO BE TESTED FOR ACANTHAMOEBA, AND THAT NO CONTACT LENS WEAR WAS ALLOWED. THE PATIENT WAS SEEN IN FOLLOW-UP ON (B)(6) 2014 WITH NO PHYSICAL EXAMINATION FINDINGS PROVIDED ON THE MEDICAL RECORDS. IT WAS NOTED THAT THE PATIENT'S COURSE WAS IMPROVING/ PROGRESSING, AS EXPECTED. THE PATIENT WAS INSTRUCTED TO CONTINUE THE PRESENT TREATMENT REGIMEN,WITH AN ADDITIONAL TREATMENT OF ACETAMINOPHEN/HYDROCODONE 5/325 MG ONE TABLET EVERY FOUR HOURS AS NEEDED FOR PAIN PRESCRIBED. THE PATIENT WAS INSTRUCTED TO RETURN THE FOLLOWING DAY. THE PATIENT WAS SEEN IN FOLLOW-UP ON (B)(6) 2014 ON THE PREVIOUSLY PRESCRIBED MEDICATIONS. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THE OD (MODERATE IN SEVERITY), SLOWLY IMPROVING. PHYSICAL EXAMINATION FINDINGS SHOWED A 1.0 MM HYPOPYON OD (LESS) WITH AN EPITHELIAL DEFECT OF 5.0 MM HORIZONTAL/ 3.0 MM VERTICAL IN THE OD. VISUAL ACUITY (WITHOUT CORRECTION) IN THE OD WAS HM (HAND MOTION), WITH AN INTRAOCULAR PRESSURE OD OF 15. THE COURSE WAS NOTED AS IMPROVING/PROGRESSING, AS EXPECTED. THE PATIENT WAS INSTRUCTED TO STOP THE ERYTHROMYCIN, START GEL TEARS, AND USE COLD PACKS FOR COMFORT. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP ON (B)(6) 2014. THE PATIENT WAS SEEN IN FOLLOW-UP ON (B)(6) 2014, EXPERIENCING SEVERE, CONSTANT EYE PAIN OD, CONTROLLED BY MEDICATION. PHYSICAL EXAMINATION FINDINGS INCLUDED AN INJECTED CONJUNCTIVA OD, A 1.0 MM HYPOPYON OD (LESS), AND AN EPITHELIAL DEFECT 3.0- 4.0 MM OD. VISUAL ACUITY (WITHOUT CORRECTION) IN THE OS WAS NOTED AS 20/400. A DIAGNOSIS OF ACANTHAMOEBA INFECTION OD WAS GIVEN AT THIS VISIT. THE PATIENT WAS SEEN IN FOLLOW-UP ON (B)(6) 2014, EXPERIENCING MODERATE EYE PAIN OD, WHICH WAS CONSTANT AND IMPROVING. PHYSICAL EXAMINATION FINDINGS INCLUDED AN INJECTED CONJUNCTIVA OD, A 1.0 MM HYPOPYON OD (IMPROVING), AND AN EPITHELIAL DEFECT OF LESS THAN 3.0 MM OD. THE TREATMENT REGIMEN REMAINED UNCHANGED, EXCEPT FOR THE SLOW DECREASE OF PAIN MEDICATIONS. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2014,WITH IMPROVEMENT IN VISUAL ACUITY AND A DECREASE IN PAIN OD. VISUAL ACUITY FINDINGS WERE HM (HAND MOTION) IN THE OD AND 20/25 OS WITH SUNGLASSES. PHYSICAL EXAMINATION FINDINGS SHOWED LESS DEBRIS IN THE ANTERIOR CHAMBER (LESS THAN 1.0 MM IN SIZE). WITH A 3.0 X 3.0 MRN EPITHELIAL DEFECT SEEN IN THE CORNEA. THE PATIENT WAS INSTRUCTED TO ADD STEROID EYE DROPS BID OD TO THE TREATMENT REGIMEN AND RETURN IN TWO DAYS FOR FOLLOW-UP. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2014 WITH LESS PAIN (NO PAIN REPORTED FOR THE PRIOR 2 - 3 DAYS), INCREASED COMFORT, AND AN ABILITY TO OPEN THE EYE BETTER (ALL OD); VISION IN OD WAS STILL DECREASED, WITH THE PATIENT STILL EXPERIENCING BLURRY VISION (EXTREME IN SEVERITY). MEDICATIONS AT THAT TIME WERE STEROID EYE DROPS BID OD, NEPAFENAC TID OD, ANTIBIOTIC EYE DROPS HOURLY OD, PHMB HOURLY, CHLORHEXIDINE HOURLY, HEXAMIDINE HOURLY, AND BACITRACIN QHS. PHYSICAL EXAMINATION FINDINGS OF THE OD INCLUDED A CONJUNCTIVA, SCLERA, EYELIDS, AND IRIS ALL WITHIN NORMAL LIMITS, AND WITH A RING ULCER HEALING (EPITHELIAL DEFECT OF 2.0 MM X 3.0 MM, IMPROVING). VISUAL ACUITY WAS NOTED AS 20/30 IN THE OS (CORRECTED), WITH HAND MOTION IN THE OD. INTRAOCULAR PRESSURES WERE WITHIN NORMAL LIMITS BILATERALLY. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP WITH THE CORNEAL SPECIALIST AS SCHEDULED AND TO RETURN TO THE ECP IN ONE WEEK. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2014, COMPLAINING OF INCREASED DISCOMFORT IN THE OD, AS WELL AS PAIN (MILD IN SEVERITY, EPISODIC IN TIMING). PHYSICAL EXAMINATION FINDINGS INCLUDED AN INJECTED CONJUNCTIVA OD, AN INJECTED SCLERA OD, AND AN EPITHELIAL DEFECT 3.0 X 4.0 OD. NO OTHER INFORMATION WAS PROVIDED; THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP IN ONE WEEK. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2014, PRESENTING WITH WORSENING PAIN IN THE OD (SEVERE IN SEVERITY, CONSTANT IN TIMING). MEDICATIONS AT THAT TIME INCLUDED PHMB, DESOMEDINE, ATROPINE, ANTIBIOTIC EYE DROPS, BACITRACIN, AND CHLORHEXIDINE (PRESENTING REGIMENS AND DOSINGS NOT PROVIDED). PHYSICAL EXAMINATION FINDINGS INCLUDED AN INJECTED CONJUNCTIVA OD, AN INJECTED SCLERA OD, AND AN EPITHELIAL DEFECT WITH A TEMPORAL STROMAL INFILTRATE OD. VISUAL ACUITY (WITHOUT CORRECTION) OD WAS HM; INTRAOCULAR PRESSURES BILATERALLY REMAINED WITHIN NORMAL LIMITS. IT WAS RECOMMENDED THAT THE PATIENT USE A BANDAGE CONTACT LENS AND RINSE WITH COLD WATER; THE PATIENT WAS INSTRUCTED TO DECREASE THE ANTIBIOTIC EYE DROPS TO BID OD, NEPAFENAC TO BID OD, AND TO STOP THE STEROID EYE DROPS (USING THE REMAINING/PREVIOUSLY PRESCRIBED MEDICATIONS AS DIRECTED). THE BANDAGE CONTACT LENS WAS PLACED AFTER INSTILLATION OF TETRACAINE OD AND PRE/POST IRRITATION WITH COOL WATER. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP IN ONE DAY, THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2014 WITH A MILD INCREASE IN PAIN OD (SEVERE IN SEVERITY AND CONSTANT/WORSENING IN TIMING); THE PATIENT HAD NOT STOPPED THE STEROID EYE DROPS AS DIRECTED THE DAY BEFORE, WITH THE LAST DOSE THE EVENING OF (B)(6) 2014. PHYSICAL EXAMINATION FINDINGS INCLUDED AN INJECTED CONJUNCTIVA OD AND AN EPITHELIAL DEFECT/INFILTRATE OD (BANDAGE CONTACT LENS NOT IN PLACE/REMOVED). IT WAS NOTED THAT THE PATIENT'S PRESCRIPTION FOR CHLORHEXIDINE HAD EXPIRED (B)(6) 2014 AND THAT THE PATIENT HAD BEEN USING THIS MEDICATION FOR 13 DAYS WITHOUT KNOWING IT HAD EXPIRED; THE PATIENT WAS GIVEN A NEW BOTTLE TO USE. THE COURSE OF THE PATIENT WAS NOTED AS PROGRESSING, AS EXPECTED. THE PATIENT WAS REMINDED NOT TO USE THE STEROID EYE DROPS AND TO CONTINUE ALL OTHER MEDICATIONS AS PRESCRIBED; THE PATIENT WAS INSTRUCTED TO RETURN IN TWO DAYS. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2014, PRESENTING WITH PAIN OD (SEVERE IN SEVERITY AND CONSTANT IN TIMING). MEDICATIONS AT THAT TIME INCLUDED CHLORHEXIDINE HOURLY, ATROPINE QD, ANTIBIOTIC EYE DROPS EVERY TWO HOURS, DESOMEDINE HOURLY, AND PHMB (REGIMEN/DOSING NOT SPECIFIED). PHYSICAL EXAMINATION FINDINGS INCLUDED BILATERAL INJECTED CONJUNCTIVAE (NO SIGNS OF INFECTION OS). THE OD CORNEA SHOWED AN EPITHELIAL DEFECT OF 3.0 MM. VISUAL ACUITY (WITHOUT CORRECTION) FOR THE OD WAS HM. THE COURSE OF THE PATIENT WAS NOTED AS IMPROVING (SLOWLY), PROGRESSING AS EXPECTED. THE PATIENT WAS INSTRUCTED TO CONTINUE THE PRESENT. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP ON (B)(6) 2014, OR SOONER IF PAIN INCREASED. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2014, PRESENTING WITH BLURRY VISION AND PAIN OD (SEVERE IN SEVERITY AND CONSTANT IN TIMING). PHYSICAL EXAMINATION FINDINGS INCLUDED AN INJECTED CONJUNCTIVA OD AND AN EPITHELIAL DEFECT OF 3.0 MM, LESS 4.0 MM INFILTRATES OD. VISUAL ACUITY (WITHOUT CORRECTION) FOR THE OD WAS HM. THE PATIENT WAS INSTRUCTED TO INCREASE THE NEPAFENAC TO QID OD, CONTINUE THE BACITRACIN BID, AND CONTINUE THE OTHER PREVIOUSLY PRESCRIBED MEDICATIONS. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP ON (B)(6) 2014. MEDICAL RECORDS RECEIVED REGARDING THE CORNEAL SPECIALIST VISIT ADDRESS A FOLLOW-UP VISIT THAT OCCURRED ON (B)(6) 2014 (THESE RECORDS WERE SUBMITTED BY THE ECP; ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CORNEAL SPECIALIST, BUT NOT YET RECEIVED). THE PATIENT PRESENTED WITH REPORTED PAIN THE NIGHT PRIOR AND RED EYE THE DAY OF THE VISIT. THE PATIENT DID HAVE REPEAT CULTURES TAKEN (B)(6) 2014 (FUNGAL, BACTERIAL, AND ACANTHAMOEBA,WITH A HIGH SUSPICION FOR ACANTHAMOEBA). PHYSICAL EXAMINATION FINDINGS SHOWED 3+ INJECTION IN THE OD WITH A 6.0 X 7.0 MM EPITHELIAL DEFECT/ 4.25 X 5.75 RING INFILTRATE WITH CENTRAL CLEARING (ALSO OD). A 1.5 MM MIXED HYPOPYON/HYPHERNA WAS SEEN IN THE OD, WITH A POOR VIEW OF THE OD LENS. THERE WAS NO VIEW OF THE OD DISC UPON FUNDUS EXAM. VISUAL ACUITY (WITHOUT CORRECTION) WAS NOTED AS CF CLOSE (COUNTING FINGERS) IN THE OD, WITH AN INTRAOCULAR PRESSURE OF 24MM/HG. IT WAS CONFIRMED THAT THE PATIENT HAD A CENTRAL CORNEAL ULCER IN THE OD, WHICH WAS NOT RESPONDING TO TREATMENT; THE PATIENT WAS INSTRUCTED TO INCREASE THE ANTIBIOTIC EYE DROPS TO EVERY TWO-HOUR DOSING, NATAMYCIN TO EVERY TWO-HOUR DOSING, AND WAS PRESCRIBED VORICONAZOLE 200 MG BID, AND ERYTHROMYCIN OINTMENT QID. THE PATIENT WAS INSTRUCTED TO START PHMB 20 PERCENT SOLUTION ONE DROP OD EVERY TWO HOURS AND CHLORHEXIDINE 0.12 PERCENT ONE DROP OD EVERY TWO HOURS. A B-SCAN SHOWED THAT NO EVIDENCE OF POSTERIOR VITRITIS OR ENDOPHTHALMITIS WAS SEEN. OCULAR HYPERTENSION WAS SOON OD (IN THE SETTING OF ACR); THE PATIENT WAS PRESCRIBED BRIMONIDINE/TIMOLOL EYE DROPS, ONE DROP BID, FOR THIS. THE PATIENT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP WITH THE CORNEAL SPECIALIST IN FIVE DAYS' TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CORNEAL SPECIALIST BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753790 DAILIES VISITINT AQUACOMFORT PLUS LENS, CONTACT (DISPOSABLE) LPL CIBA VISION CORPORATION A0391075

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention