BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 6074386 · Received November 2, 2016

    Report

    Report Number
    1033553-2016-00129
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    July 10, 2016
    Report Date
    October 10, 2016
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 WHILE WEARING THE ACUVUE OASYS BRAND CONTACT LENSES THAT HE/SHE "WAS NOT GETTING ENOUGH OXYGEN TO HER EYE BECAUSE SHE WAS WEARING HER CONTACTS TOO LONG AND NOT TAKING THEM OUT." THE PT REPORTED THAT THE EVENT OCCURRED A COUPLE OF MONTHS AGO AND THE PRODUCT IS NO LONGER AVAILABLE. A CALL WAS PLACED TO THE PTS TREATING EYE CARE PROVIDER (ECP) AND REQUESTED ADDITIONAL MEDICAL INFORMATION. ON 10OCT2016 THE PTS MEDICAL RECORDS WERE RECEIVED AND THE ADDITIONAL INFORMATION WAS OBTAINED AS FOLLOWS: MEDICAL RECORDS: DATE OF VISIT: (B)(6) 2016. COMPLAINT: (B)(6) FEMALE COMPLAINS OF RED PAINFUL OD. THE TIMING IS DESCRIBED AS CONSTANT. CONTEXT - CL; UNCOMFORTABLE SINCE LAST PM, REMOVED; SLEEPS IN CLS, REMOVES 2X/WK. SEVERITY - 7/10; 10/10 PAIN IN BRIGHT LIGHTS. SYMPTOMS: PAIN, REDNESS, WATERING, FBS, PHOTOSENSITIVITY. PATIENT DECLINES PRESENCE OF PURULENT DISCHARGE VISUAL ACUITIES: CC DISTANCE OD: 30 +2. IRIS: BLUE. INTRAOCULAR PRESSURE OD: AUTOREFRACT: -2.50; CYL: -1.00; AXIS: 13. PD DISTANCE TOTAL OD: 64. ANTERIOR EXAM OD: BULBAR: 2+ INJECTION NASAL; 1+ DIFFUSE INJECTION. CORNEA: EPITHELIUM: STIPPLING/STAINING OVER INFILTRATE. STROMA: STERILE SEI INF-CENTRAL W/OVERLYING STIPPLING/STAINING. ANTERIOR CHAMBER: TRACE + CELLS. CELLS: 1+. POSTERIOR EXAM OD: NEGATIVE. DIAGNOSIS AND PLAN: CENTRAL CORNEAL ULCER OD. ASSESSMENT: STERILE SEI INF-CENTRAL OD W/OVERLYING STIPPLING/STAINING; 1+ CELLS OD; 2+ NASAL INJECTION, 1 + DIFFUSE INJECTION; PT WEARS CLS EW, REMOVES 1-2X/WK PLAN: INFORMED/EDUCATED ON CONDITION, SYMPTOMS, RISK FOR PROGRESSION. PT STATES ALLERGIC TO TOBRADEX - DC'D TOBRADEX. RX: PRED FORTE AND POLYTRIM OD BOTH Q HOUR DAY 1, THEN QID FOLLOWING. RTC 3 D TO MONITOR. D/C CL WEAR INDEFINITELY. PLAN TO SWITCH TO DD DISPOSABLE OR H202 SOL W D/C EW ONCE RESOLVED. MONITOR 3 D. DATE OF VISIT: (B)(6) 2016. COMPLAINT: (B)(6) FEMALE COMPLAINS OF RED PAINFUL EYE OD, CHECK IN OD. THE TIMING IS DESCRIBED AS INTERMITTENT. QUALITY IS IMPROVING. CONTEXT - OUT OF CLS; SEVERITY - NO PAIN NOW MEDS: POLYTRIM OPHTH SOLUTION 1-2 DROPS STARTED (B)(6) 2016; PREDNISONE 0.12% - START (B)(6) 2016 VA OD: 20/20 -1. INTRAOCULAR PRESSURE OD: 22; ANTERIOR EXAM OD: BULBAR: INJECTION: MILD; CORNEA: EPITHELIUM: SUPERFICIAL PUNCTATE KERATITIS; POSTERIOR EXAM OD: OPTIC DISK: NORMAL; RATIO: 0.4/0.4; APPEARANCE: NORMAL. NERVE FIBER LAYER: NORMAL; RETINA OD: MACULA: NORMAL; VESSELS: NORMAL; PERIPHERY: NORMAL; CONTACT LENS INFORMATION OD: ACUVUE 1-DAY MOIST: SPHERICAL; -2.75; 8.4; 14.0 DIAGNOSIS AND PLAN: CENTRAL CORNEAL ULCER OD. ASSESSMENT: STERILE SEI INF-CENTRAL OD W/OVERLYING STIPPLING/STAINING; 1+ CELLS OD; 2+ NASAL INJECTION, 1 + DIFFUSE INJECTION; PT WEARS CLS EW, REMOVES 1-2X/WK. PLAN: INFORMED/EDUCATED ON CONDITION, SYMPTOMS, RISK FOR PROGRESSION. PT STATES ALLERGIC TO TOBRADEX - DC'D TOBRADEX. RX: PRED FORTE AND POLYTRIM OD BOTH Q HOUR DAY 1, THEN QID FOLLOWING. RTC IF NO BETTER. D/C CL WEAR INDEFINITELY. PLAN TO SWITCH TO DD DISPOSABLE ASSESSMENT: PUNCTATE KERATITIS OD. EXAMINATION REVEALED CORNEAL ULCER; HEALING NICELY; EXAMINATION REVEALED SUPERFICIAL KERATITIS. PLAN: REVIEWED CAUSE AND TREATMENT PLAN. DISCONTINUE CONVENTIONAL WEAR OF CLS; DAILY DISPOSABLE RECOMMENDED AT THIS TIME. DATE OF VISIT: (B)(6) 2016. COMPLAINT: (B)(6) FEMALE CL CHECK IN OU; CONTEXT - SWITCHED TO DAILIES, ACUVUE 1-DAY MOIST/TORIC OS; SYMPTOMS: CENTRAL CORNEAL ULCER/SEI OD; RESOLVED X 7 D; POLYTRIM/PRED QID; PATIENT DECLINES PRESENCE OF BLURRED VISION, PAIN, REDNESS, DISCHARGE MEDS: POLYTRIM OPHTH SOLUTION 1-2 DROPS STARTED (B)(6) 2016; PREDNISONE 0.12% - START (B)(6) 2016. VISUAL ACUITY OD: 20. CORNEAL EVALUATION OD: CLEAR. DIAGNOSIS AND PLAN: CENTRAL CORNEAL ULCER OD. ASSESSMENT: CENTRAL CORNEAL ULCER/SEI OD 2 WEEKS AGO; RESOLVED X 7 D ON POLYTRIM/PRED FROTE QID; SWITCHED TO DAILY DISPOSABLES. PLAN: INFORMED/EDUCATED ON CONDITION; PT HAPPY WITH DAILY DISPOSABLES - VA, COMFORT. GOOD FIT. ELIGIBLE W INS FOR NEW CLS (B)(6), DOES NOT WANT TO PURCHASE SUPPLY OF DAILIES UNTIL THEN. OK TO WEAR AIR OPTIX UNTIL (B)(6). SWITCH TO CLEAR CARE SOL. REVIEWED CL CLEANING/WEAR/REPLACEMENT SCHEDULE. NO SLEEPING IN LENSES, NO EW, MONTHLY REPLACEMENT. STRESSED COMPLIANCE. RTC (B)(6) FOR CEE/CL EVAL. SWITCH BACK TO DAILIES OR HIGHER DW W H202 SOL. MONITOR. THE LOT NUMBER OF THE SUSPECT PRODUCT IS UNKNOWN AND THE PRODUCT IS NOT AVAILABLE. 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
    725188 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA UNK-PH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 Other| R