BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 6113773 · Received November 18, 2016

    Report

    Report Number
    1033553-2016-00141
    Event Type
    Injury
    Date Received
    November 18, 2016
    Report Date
    October 26, 2016
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016 A CALL WAS RECEIVED FROM A PATIENT (PT) WHO REPORTED THAT HE/SHE ¿HAD A FUNGUS IN HIS/HER OD OVER TWO YEARS AGO.¿ THE PT REPORTED THAT ¿IT WAS TOTALLY MY FAULT AND NOT THE FAULT OF THE LENSES.¿ THE PT REPORTED THAT HE/SHE WAS ¿WEED WHACKING AND WAS NOT WEARING GOGGLES.¿ THE PT REPORTED THAT THE EVENT BEGAN IN (B)(6) 2014. IT WAS REPORTED THAT THE PT WAS WEARING AN ACUVUE OASYS BRAND CONTACT LENS. THE PT DID NOT RETAIN THE LOT NUMBER AND NO PRODUCT IS AVAILABLE FOR RETURN FOR EVALUATION. A CALL WAS PLACED TO THE PTS TREATING EYE CARE PROFESSIONAL (ECP) AND ADDITIONAL MEDICAL INFORMATION WAS REQUESTED. THE PTS MEDICAL RECORDS WERE RECEIVED ON 03NOV2016. MEDICAL RECORDS SUMMARY: DATE OF VISIT: (B)(6) 2014. CHIEF COMPLAINT: PT C/O ABOUT 3 WEEKS AGO GOT AN ABRASION FROM A PIECE OF DIRT WHEN WEED WHACKING ¿ WENT TO ER & IT WAS REMOVED. HPI: (B)(6) F PRESENTS FOR PAIN/RED ¿ OD X 2 DAYS; WORE HER CLS THIS WEEKEND, SLEPT IN THEM OVER THE WEEKEND; TOOK THEM OUT EITHER SUNDAY OR MONDAY PM; + RED, + PAIN, + SORE, + FBS MEDS: E-MYCIN UNG 4-5, BURNS. VA OD W/SC: 20/20; NO CLS IN. OD: SUPERFICIAL KERATITIS; < 1 MM DEFECT; D/ RARE CELL. ASSESSMENT/PLAN: 1. SUPERFICIAL KERATITIS 2ND TO CL OVER WEAR; 2. EPI DEFECT ¿ OD. PLAN: VIGAMOX Q 2 H; STAY OUT OF CLS X 1 WEEK; CONTINUE E-MYCIN UNG HS; START OASIS 4/PRN. DATE OF VISIT: (B)(6) 2014. CC: IT FEELS LIKE SOMETHINGS IN IT, LIKE SAND. HPI: (B)(6) F PRESENTS FOR DAY RECHECK SUPERFICIAL KERATITIS 2ND CORNEAL ULCER; + RED, + BURNING, + PAIN, + FBS. VA OD SC: 20/25 25. EXAM OD: CONJ: + INJECTION; ANTERIOR CHAMBER: NO CELLS; DRAWING DEPICTS: SMALL DENSE INFILTRATE W/ SPK SURROUND. ASSESSMENT/PLAN: 1. SPK OD 2ND TO CL OVERWEAR W/EPI DEFECT. PLAN: DECREASE VIGAMOX TO Q 3 H; INCREASE OASIS TO Q 3 H; CONTINUE E-MYCIN ONLY Q HS; OK TO CHANGE TO OCUFLOX WHEN RUNS OUT; STILL NO CL USE, CONSIDER DAILY DISP IN FUTURE; RETURN TUESDAY. DATE OF VISIT: (B)(6) 2014. CC: FEELS LIKE SAND PAPER, I RUBBED MY EYE SUNDAY NIGHT AND NOW IT REALLY HURTS AGAIN. HPI: (B)(6) F PRESENTS FOR RECHECK ¿ SPK OD 2ND TO CL OVERWEAR WITH EPI-DEFECT; + PAINFUL, + FBS, + DISCHARGE, + REDNESS, + BURNING. VA OD SC: 20/30 25; BEEN SLEEPING WITH PATCH OD SINCE SUNDAY. EXAM OD: A/C: NO CELL; DRAWING DEPICTS SMALL DENSE INFILTRATE; STAINING W/ SPK SURROUND. ASSESSMENT/PLAN: 1. KERATITIS OD; CONTINUE PREVIOUS MEDS; VIGAMOX OR OCUFLOX MAY BE USED FOR ANTIBIOTICS. DATE OF VISIT: (B)(6) 2016. CC: C/O DRYNESS ¿ OD; + BURNING ¿ OD; PT STATES NO CHANGES WITH VA; + INJECTION OD. HPI: (B)(6) F PRESENTS FOR KERATITIS RECHECK AS DIRECTED - OD. VA OD: 20/40 -1; DIDN¿T BRING GLASSES. EXAM OD: CONJ: 1+ INJECTION; CORNEA: 1 MM DEFECT. ASSESSMENT/PLAN: KERATITIS OD; 1 MM DEFECT; ? FUNGAL; REC CX TODAY; MEDS: OXAFLOXACIN Q2 H; OASIS Q1 H; E-MYCIN UNG Q HS; PATCHING EYE @ NIGHT. RETURN ON MONDAY FOR RECHECK. DATE OF VISIT: (B)(6) 2016. CC: OD FEELS THE SAME, + BURNING, PHOTOPHOBIA, RED, SWOLLEN; ¿I KEPT IT PATCHED ALL WEEKEND. VA OD SC: 20/25 20. EXAM OD: CONJ: + INJ; CORNEA: KERATITIS. ASSESSMENT/PLAN: 1. KERATITIS OD; PLAN: IF FUNGAL REPORTS COMES BACK +, START ANTIFUNGAL AGENTS; MEDS: OCUFLOX Q 2H; OASIS Q 1 H; E-MYCIN UNG @ HS; PATCHING ALL WEEKEND. RETURN ON WED. DATE OF VISIT: (B)(6) 2014. CC: C/O BURNING OD; + TEARING, + FBS, + NEW WHITE SPOT @ 2 O¿CLOCK; + FILM OVER EYE; ¿MY EYE LOOKS LIKE A RAISIN¿. HPI: PRESENTS FOR KERATITIS RECHECK. VA OD SC: 20/25. EXAM OD: CONJ: TR INJ FLUFFY; CORNEA: INFILTRATE @ 2 O¿CLOCK; A/C: NEG EPI DEFECT. ASSESSMENT/PLAN: KERATITIS OD, NO IMPROVEMENT; - CULTURE RESULTS REVIEWED - RECOMMEND DIFFERENT AB, IF NOT IMPROVED BY MONDAY RE CULTURE OR EMPIRICALLY START D-FUNGAL - ZYMAXID Q 1 H - IF ANY WORSE, INCREASED PAIN, INCREASED RED, INCREASED DISCHARGE CALL ASAP MEDS: OCUFLOX Q 2 H; OASIS Q 1 H; PATCHING AT NIGHT RETURN MONDAY PM. DATE OF VISIT: (B)(6) 2014. CC: IT STILL FEELS LIKE SOMETHING IS IN MY EYE. HPI: PRESENTS FOR 6 DAY KERATITIS RE CHECK; + PAIN; + LIGHT SENSITIVE; NEG DISCHARGE; + FBS VA OD SC: 20/25. EXAM OD: CONJ: TR INJ; CORNEA: 1 MM PIN PT STAINING NEAR INFILTRATE; A/C: NO HYPOPYON. ASSESSMENT/PLAN: 1. KERATITIS OD. PLAN: D/C MEDS; START NATAMYCIN 5 % Q 2 H W/A. RE-CHECK WED. DATE OF VISIT: (B)(6) 2014. CC: DECREASED FBS ¿ OD; INC REDNESS; + SWELLING. HPI: KERATITIS RE-CHECK. VA OD SC: 20/25. EXAM OD: CONJ: 1 + INJ; CORNEA: KERATITIS W/ LOCALIZED EDEMA; NO EPI DEFECT. ASSESSMENT/PLAN: KERATITIS OD; ? FUNGAL CX (-) TO DATE; EPI DEFECT; CONTINUE NATAMYCIN Q 2 H TODAY, THEN Q 4 H. RETURN MONDAY. TELEPHONE MESSAGE: DATE: (B)(6) 2014. MESSAGE: PT CALLED STATING CO-WORKER NOTICED BUMPS BEHIND EAR ¿ WONDERED IF RELATED TO NATAMYCIN. PT TOOK BENADRYL & BUMPS ARE GONE. HAS USED NATAMYCIN SINCE WITH NO REOCCURRENCE. TOLD PT TO CONTINUE NATAMYCIN & IF BUMPS REOCCUR CALL OFFICE. PT STATES SHE FEELS FINE WITH NO PROBS W/ PULSE, NAUSEA, FAINTING SPELLS ¿ FEELS NORMAL. DATE OF VISIT: (B)(6) 2014. CC: I THINK ITS FEELING BETTER. HPI: KERATITIS RE-CHECK OD; + FBS (IMPROVING), + REDNESS (IMPROVING). VA OD SC: 20/25 25. EXAM OD: CORNEA: PERIPHERAL KERATITIS; PIN PT STAIN. ASSESSMENT/PLAN: KERATITIS OD ¿ LIKELY FUNGAL, BUT CULTURE NEG; K DEBRIDEMENT TODAY; CONTINUE PRESENT MEDS; CULTURE REPORT: NO GROWTH. MEDS: NATAMYCIN 4/0; OASIS Q 1 H. RETURN 1 WEEK. TELEPHONE MESSAGE: DATE (B)(6) 2014. MESSAGE: PT SPILLED LARGE AMOUNT OF HER DROPS AND ONLY HAS ENOUGH FOR A CPL DAYS. WOULD LIKE REFILL FOR NATAMYCIN TO INCLUDE NEW INSTRUCTIONS (EVERY 4 HOURS INSTEAD OF Q 2 H). DATE OF VISIT: (B)(6) 2014. CC: PT C/O ON SAT/SUN COULDN¿T OPEN OD X 1 HOUR; STATES FEELS LIKE SOMETHING STABBING HER IN OD; + CONSTANTLY POURING WATER X DAYS; + RED. VA OD SC: 20/25. EXAM OD: CONJ: TR INJ; CORNEA: KERATITIS OD. ASSESSMENT/PLAN: KERATITIS OD ¿ IMPROVING, LIKELY FUNGAL; USE TEARS AFTER NATAMYCIN; NATAMYCIN 2/0 RETURN 2 WEEKS RECHECK. DATE OF VISIT: (B)(6) 2016. CC: NO DISCOMFORT; ¿STILL LOOKS THE SAME¿ ; + PHOTOPHOBIA OD. HPI: KERATITIS RECHECK. VA OD SC: 20/25; TAPP/PEN OD: 10. EXAM OD: CORNEA: < 1MM KERATITIS; DECREASED KERATITIS W/ TR K OPACITY; NEG EPI DEFECT. ASSESSMENT/PLAN: KERATITIS OD ¿ SUSPICIOUS FOR FUNGAL BUT (-) TO DATE; DECREASE NATAMYCIN 3/0; OASIS Q 1H. RETURN 2 WEEKS. DATE OF VISIT: (B)(6) 2014. CC: PT C/O + RED - OD. HPI: RECHECK KERATITIS OD. VA OD SC: 20/20. EXAM OD: CONJ: INF INJ (-) STAINING. ASSESSMENT/PLAN: KERATITIS OD ¿ RESOLVING 2ND FUNGAL. PLAN: DISCUSSED A TEARS AFTER NATAMYCIN 2/0. RETURN 3 WEEK RECHECK OD. DATE OF VISIT: (B)(6) 2014. CC: KERATITIS RECHECK. HPI: PT STATES NO DISCOMFORT WITH EYES. EXAM OD: ANTERIOR SEGMENT: EYELIDS AND LASHES RIGHT: BLEPHARITIS LOCATION: EYE LIDS AND LASHES; CONJ OD: WHITE/QUIET; CORNEA RIGHT: TEAR FILM DECREASED: PUNCTATE KERATOPATHY, K-SCAR; A/C: DEEP AND QUIET. ASSESSMENT/PLAN: KERATITIS OD DECREASED NATAMYCIN 1/0 AND INCREASED AT¿S 4/4. RETURN TO OFFICE (B)(6) 2014. NO ADDITIONAL MEDICAL INFORMATION IS EXPECTED. 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
    763580 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 Other| R