BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE CLEAR

    MDR report key: 5957259 · Received September 16, 2016

    Report

    Report Number
    1033553-2016-00099
    Event Type
    Injury
    Date Received
    September 16, 2016
    Report Date
    August 24, 2016
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2016 OUR AFFILIATE IN (B)(6) RECEIVED A CALL FROM A PATIENT (PT) WHO REPORTED A "SEVERE CASE OF CORNEAL ULCER" IN (B)(6) 2012 WHILE WEARING THE ACUVUE CLEAR BRAND CONTACT LENS. THE PT REPORTED THAT HE/SHE EXPERIENCED OCULAR DISCOMFORT INITIALLY AND THE FOLLOWING DAY THE PT REPORTED THAT HE/SHE COULDN'T OPEN THE EYE AND HAD "WHITE DISCHARGE." THE PT REPORTED THAT THE CORNEAL ULCER WAS "CENTER TO EDGE." THE PT REPORTED THAT HE/SHE HAS CORNEAL SCARRING. THE PT ALSO REPORTED THAT THERE IS NO BLURRED VISION DUE TO THE SCAR, BUT "CAN SEE IT UNDER LIGHT." THE PT REPORTED THAT THE EYE CARE PROVIDER (ECP) PRESCRIBED EYE DROPS EVERY HOUR, "2-3 DROPS," EYE OINTMENT, AND EYE LUBRICANT. THE PT REPORTED THAT "SOMETIMES HE/SHE DIDN'T CHANGE SOLUTION AS THE PT WAS TOO LAZY." ON (B)(6) 2016 AN EMAIL WAS RECEIVED WITH THE PTS MEDICAL RECORDS FROM THE 2012 CORNEAL ULCER EVENT. THE ADDITIONAL INFORMATION WAS OBTAINED AS FOLLOWS: "MEDICAL REPORT PAGE 1: CULTURE AND ANTIBIOTIC SUSCEPTIBILITY TEST [COLLECTED ON (B)(6) 2012, REPORTED ON (B)(6) 2012]; SPECIMEN: CONTACT LENS; SOURCE: RIGHT EYE; GRAM'S STAIN: OCCASIONAL EPITHELIAL CELLS, MODERATE GRAM POSITIVE BACILLI AND GRAM NEGATIVE BACILLI SEEN; ORGANISM ISOLATED -1 : PSEUDOMONAS AERUGINOSA - HEAVY GROWTH; ORGANISM ISOLATED - 2: SERRATIA SPECIES - HEAVY GROWTH. MEDICAL REPORT PAGE 2: CULTURE AND ANTIBIOTIC SUSCEPTIBILITY TEST [COLLECTED ON (B)(6) 2012, REPORTED ON (B)(6) 2012]; SPECIMEN: CONTACT LENS; SOURCE: LEFT EYE; GRAM'S STAIN: FEW GRAM POSITIVE BACILLI AND MANY GRAM NEGATIVE BACILLI SEEN; ORGANISM ISOLATED -1 : PSEUDOMONAS AERUGINOSA - HEAVY GROWTH; ORGANISM ISOLATED - 2: SERRATIA SPECIES - HEAVY GROWTH. MEDICAL REPORT PAGE 3: DATE: (B)(6) 2012; RIGHT EYE; EYE DROP ZYMAXID, 4 TIMES/DAY X 3 DAYS; GENTEAL GEL, 3 TIMES/DAY X 1 MONTH; CIPLOX EYE OINTMENT, HS X 1 WEEK. MEDICAL REPORT PAGE 4: ZYMAXID DROP, EVERY ONE HOUR FOR 3 DAYS, 4/DAY X 3 DAYS; GENTEAL GEL, EVERY 1 HOUR X 3 DAYS GIVE 10 MIN GAP, X3/DAY X 1 MONTH; CIPLOX OINTMENT AT BEDTIME X 1 WEEK RIGHT. MEDICAL REPORT PAGE 5: [DATE: (B)(6) 2012]; FORTIFIED CEFTAZIDIME DROP; EVERY 1 HOUR, RIGHT EYE; [DATE: (B)(6) 2012]; EVERY 2 HOURS - ALL THE DROP. MEDICAL REPORT PAGE 6: CONTACT LENS - FOR CULTURE + SUSCEPTIBILITY. MEDICAL REPORT PAGE 7: TOBA F DROP /---/---/ WEEK; PATADAY DROP /------/ FINISH". NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL MEDICAL INFORMATION IS EXPECTED. THE PT REPORTED THAT HE/SHE WEARS CONTACT LENSES EIGHT HOURS A DAY. THE LOT NUMBER IS UNKNOWN AND THE PRODUCT IS NOT AVAILABLE FOR RETURN FOR EVALUATION. 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
    609128 ACUVUE CLEAR LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA UNK-EMG

    Patients

    Seq Age Sex Outcome Treatment
    1 25 Other| R| S