BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 5651185 · Received May 12, 2016

    Report

    Report Number
    1033553-2016-00058
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    March 21, 2016
    Report Date
    April 18, 2016
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016 A PATIENT (PT) CALLED TO REPORT THAT HE/SHE HAD AN "EYE INFECTION" IN THE OD AFTER WEARING AN ACUVUE OASYS BRAND CONTACT LENS FOR APPROXIMATELY THREE DAYS. THE PT ALSO REPORTED THAT HE/SHE WAS TREATED WITH PREDNISONE EYE DROPS QID AND ANOTHER EYE DROP (MEDICATION NAME IS UNKNOWN) TID FOR ONE WEEK. THE PT REPORTED THAT THE "INFECTION" IMPROVED, BUT THE PT DIDN'T FEEL THAT IT WAS COMPLETELY RESOLVED. THE MEDICAL RECORDS WERE RECEIVED FROM THE PTS TREATING EYE CARE PROVIDER (ECP). DATE OF VISIT: (B)(6) 2016. REASON FOR VISIT: FOLLOW-UP VISIT - RESOLVED IRITIS OD; BLEPHARITIS OU. HPI: CC: REDNESS OD; LOCATION OD. SINCE LAST VISIT: DURATION OF PROBLEM: < 1 DAY. ACTIVITY AFFECTED: CL USE, SEVERITY: MILD. OTHER: PATIENT HAS NOT WORN HIS CL SINCE LAST NIGHT. PATIENT WOKE WITH REDNESS OD. ALLERGIES: BIAXIN; SUN DRIED TOMATOES. SYSTEMIC MEDS: PROPECIA 1 MG ORAL TABLET QD PO. VA OD: CC 20/20 GLASSES; IOP: TP: OD: 16. IMPRESSION: PRIMARY: ANTERIOR SCLERITIS OD; IRITIS OD; BLEPHARITIS OU; VITREOUS FLOATERS OD PLAN: ANTERIOR SCLERITIS OD: PATIENT IS A CONTACT LENS WEARER WITH OCCASIONAL OVERUSE. HE NOTED RECURRENT REDNESS IN NASAL CORNER OF HIS RIGHT EYE, WHICH IMPROVED WITH PREDNISONE/DUREZOL LAST VISIT. PATIENT DENIES ANY MEDICAL ISSUES. HE DENIES RISK FACTORS FOR INFECTIONS. ROS NEGATIVE FOR JOINT PAINS, FEVER, WT LOSS, NIGHT SWEATS, ETC. DISCUSSED WITH PT HE WILL NEED WORKUP FOR SCLERITIS/IRITIS. EXTENSIVE DISCUSSION REGARDING POSSIBLE CAUSES, TREATMENT COURSE, ETC. HE DECLINED ORAL TREATMENT WITH NSAIDS. WILL RESTART PREDNISOLONE QID OD; LAB SLIP GIVEN. F/U IN 1-2 WEEKS, HERE OR WITH SPECIALIST DR. SCLERITIS WORKUP SUGGESTED. PATIENT UNDERSTANDS CONDITION, PROGNOSIS AND NEED FOR FOLLOW UP CARE. IRITIS OD; PATIENT FIRST PRESENTED (B)(6) 2016 WITH RED IRRITATED EYE. PT REPORTS THAT CHILD WAS SICK 1-2 WEEKS PRIOR AND SUBSEQUENTLY FELT FATIGUE. ON (B)(6) 2016 EYE PRESENTATION IS VERY SIMILAR TO VIRAL, HOWEVER HE HAD IRITIS. REPORTS SOME IMPROVEMENT IN SYMPTOMS WITH TOBRADEX QID OD, BUT REPORTS COURSE GOT WORSE AFTER A COUPLE OF DAYS. ON (B)(6) 2016 GIVEN RX FOR PRED FORTE 1 GTT Q2 H OD WITH MILD IMPROVEMENT. HE WAS THEN STARTED ON DUREZOL Q 3 H (DUE TO 4+ CELL) AND THEN SWITCHED BACK TO PRED FORTE Q2 HRS OD. PT SELF D.C'ED DROPS (B)(6) 2016. NO SIGNS OF INFLAMMATION ON SUBSEQUENT VISIT. PATIENT EDUCATED THAT AT THIS POINT IT IS IDIOPATHIC IN NATURE, HOWEVER IF PATIENT HAS ANOTHER EPISODE WE WILL HAVE TO RUN BLOODWORK. SEE SCLERITIS ABOVE. BLEPHARITIS OU; DISCUSSED LID HYGIENE, WARM COMPRESSES AND EYELID WASH. VITREOUS FLOATERS OD: RECOMMEND OBSERVATION. OCULAR MEDS: NONE; FOLLOW-UP: 1-2 WEEKS DATE OF VISIT: (B)(6) 2016. REASON FOR VISIT: FOLLOW-UP - ANTERIOR UVEITIS OD. IRITIS OD. HPI: CC: F/U IRITIS OD. SINCE LAST VISIT: IMPROVING. PERTINENT NEGATIVES: OD IS NO LONGER RED, NO LONGER FEELING PRESSURE IN THE EYE. SECONDARY: LATTICE DEGENERATION OD. OCULAR MEDS (INITIAL): DUREZOL 0.05% 1 GTT QID OD. CYCLOGYL 1% 1 GTT Q HS OD. SYSTEMIC MEDS: PROPECIA 1 MG ORAL TABLET. ALLERGIES: BIAXIN. VA OD: SC 20/20-1; IOP: 19. DILATION: TECH: OD: CORNEA - EPITHELIUM INTACT. CLEAR STROMA. CLEAR ENDOTHELIUM; ANTERIOR CHAMBER: TRACE CELL/FLARE; IRIS: NO IRIS NODULES. NO RUBEOSIS; LENS: CLEAR IMPRESSION/PLAN: ANTERIOR UVEITIS OD; IRITIS OD. THE PT WAS ASKED TO GET AN EXTENSIVE SEROLOGICAL WORKUP IN AN EFFORT TO IDENTIFY ANY SYSTEMIC AUTOIMMUNE OF INFECTIOUS ETIOLOGY AS THE CAUSE FOR THEIR SEVERE INFLAMMATION. REDUCE DUREZOL TO TWICE A DAY OD ONLY FOR 10 DAYS. WILL TAPER TO ONCE A DAY IF IRITIS IMPROVING IN 1 WEEK. ONE DROP CYCLOGYL AT BEDTIME, RIGHT EYE ONLY. OTHER DISCUSSION: OK TO RESUME CTLS OCULAR MEDS (FINAL): DUREZOL 0.05% 1 GTT BID OD; CYCLOGYL 1% 1 GTT QHS OD FOLLOW-UP: 1 WEEK - FOLLOW-UP EXAM ON IDIOPATHIC IRITIS OD. DATE OF VISIT: (B)(6) 2016. REASON FOR VISIT: FOLLOW-UP IRITIS OD. HPI: CC: 1 WEEK F/U IRITIS OD. SINCE LAST VISIT: EYE FEELS COMFORTABLE. MODIFYING FACTORS: USING DUREZOL BID OD; CYCLO Q HS OD. OCULAR MEDS (INITIAL): DUREZOL 0.05% 1 GTT BID OD; CYCLOGYL 1% 1 GTT QHS OD. SYSTEMIC MEDS: PROPECIA 1 MG ORAL TABLET. ALLERGIES: BIAXIN. VA OD: SC 20/20-1; IOP: 17. RX: OD: SOFT CL RX GIVEN: OASYS 1 DAY -1.00; BC 8.5; DIA 14.3 -TRIALS. FINDINGS OD: CENTRATION: CENTERED: MOVEMENT: NORMAL. DILATION: TECH: OD: CORNEA -EPITHELIUM INTACT. CLEAR STROMA. CLEAR ENDOTHELIUM; ANTERIOR CHAMBER: TRACE CELL/FLARE, NO CELLS; IRIS: NO IRIS NODULES. NO RUBEOSIS; LENS: CLEAR IMPRESSION/PLAN: IRITIS OD. REDUCE DUREZOL TO ONCE DAILY, RIGHT EYE ONLY FOR 2 WEEKS. STOP CYCLOGYL. MYOPIA OU; CONTACT LENS EXAM OU. ON (B)(6) 2016: PT FIT WITH DAILY DISPOSABLE CONTACT LENSES. SAMPLES GIVEN. NO CHARGE. OTHER DISCUSSION: OK TO RESUME CTLS, SUGGESTED TO RT FOR RE-FIT W/DAILY DISP. OCULAR MEDS (FINAL): DUREZOL 0.05% 1 GTT QD OD. DC CYCLOGYL FOLLOW-UP: 2 WEEKS -FOLLOWUP EXAM, RESOLVED IRITIS OD. DATE OF VISIT: (B)(6) 2016. REASON FOR VISIT: FOLLOW-UP IRITIS OD. HPI: CC: IRITIS OD. MODIFYING FACTORS: PT USING DUREZOL QOD IN HIS RIGHT EYE. OTHER: VISION IN CTLD NOT QUITE RIGHT. OCULAR MEDS (INITIAL): CUREZOL 0.05% 1 GTT QOD OD. SYSTEMIC MEDS: PROPECIA 1 MG ORAL TABLET. ALLERGIES: BIAXIN. VA OD: DCC20/20; IOP: 19. RX: SOFT CL RX GIVEN: OD: -1.00, BC 8.5, DIA 14.3 OASYS 1 DAY. RX: OD: MR DRY: -1.00. RX: OD: AR DRY -1.00. DILATION TECH: ANTERIOR: OD: L/C/S: TRACE OILY; CORNEA: EPITHELIUM INTACT. CLEAR STROMA. CLEAR ENDOTHELIUM; ANTERIOR CHAMBER: NORMAL DEPTH. QUIET; IRIS: NO IRIS NODULES. NO RUBEOSIS; LENS: CLEAR IMP/PLAN: IRITIS OD - DUREZOL EVERY OTHER DAY RIGHT EYE FOR 4 DOSES THEN EVERY 3RD DAY UNTIL RETURNS IN 1 MONTH; LATTICE DEGENERATION OD; BLEPHARITIS OU; MYOPIA OU; CONTACT LENS EXAM OU: ---ON (B)(6) 2016: PT FIT WITH DAILY DISPOSABLE CONTACT LENSES. OK TO ORDER. PROCEDURE: CONTACT LENS FITTING OU. DIAGNOSIS MYOPIA. OCULAR MEDS (FINAL): DUREZOL 0.05% 1 GTT QOD OD. FOLLOW-UP: 1 MONTH - INTERMEDIATE EXAM F/U IRITIS OD ON DAY WHEN OFF DROPS FOR 2 DAYS. THE SUSPECT PRODUCT HAS NOT BEEN DISCARDED. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT B00K729 WAS PRODUCED UNDER NORMAL CONDITIONS. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305386 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US B00K729

    Patients

    Seq Age Sex Outcome Treatment
    1 34 Other| R