BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE2 DEFINE

    MDR report key: 4958128 · Received July 31, 2015

    Report

    Report Number
    1033553-2015-50002
    Event Type
    Injury
    Date Received
    July 31, 2015
    Report Date
    July 13, 2015
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ON 21AUG2015 THE AFFILIATE IN (B)(4) VISITED THE PATIENT¿S (PT) TREATING EYE CARE PROFESSIONAL (ECP) AT THE HOSPITAL. THE FOLLOWING MEDICAL INFORMATION WAS RECEIVED AS FOLLOWS: ¿ON (B)(6) 2015, THE PT CAME TO A HOSPITAL ON THE REFERRAL FROM AN EYE CLINIC; DIAGNOSIS: INFECTIOUS CORNEAL ULCER OD; INFECTIVENESS: ADMITTED; CULTURE: NOT CONDUCTED SINCE EYE-DROP TREATMENT BY EYE CLINIC ALREADY STARTED; VA AFFECT: ADMITTED; CORRECTED VA OD: COUNTING FINGER; FOCAL SITE: LOWER PART OF THE CENTRAL CORNEA; TREATMENT: TOBRACIN OPHTHALMIC SOLUTION, PRESCRIBED BY EYE CLINIC, Q HR OD, CRAVIT OPHTHALMIC SOLUTION, PRESCRIBED BY EYE CLINIC, Q HR OD, AND TARIVID EYE OINTMENT, PRESCRIBED BY THE HOSPITAL, BEFORE BEDTIME OD; INSTRUCTION TO DISCONTINUE CL WEAR: OVER THE ENTIRE TREATMENT PERIOD; INSTRUCTION RTC: INSTRUCTED CAUSAL RELATIONSHIP WITH CL: THE ECP STRONGLY AFFIRMED IT; SERIOUSNESS: SERIOUS. ON (B)(6) 2015, THE PT RETURNED TO THE HOSPITAL; SYMPTOM AND PROGRESS: CLOSE TO HEAL WITH SCAR FORMATION EVEN THOUGH SLIGHT CORNEAL EPITHELIAL DEFECT WAS CONFIRMED. VA AFFECT: ADMITTED CORRECTED VA OD: NOT MEASURED SINCE THE CONDITION WAS NOT GOOD; TREATMENT: SANBETASON OPHTHALMIC AND OTORHINOLOGIC SOLUTION 0.1% INSTRUCTION TO DISCONTINUE CL WEAR AND RTC: INSTRUCTED. ON (B)(6) 2015, THE PT RETURNED TO THE HOSPITAL. SYMPTOM AND PROGRESS: IT HEALED WITH SCAR FORMATION AND RECOVERY WAS CONFIRMED. CORNEAL OPACITY IMPROVED THANKS TO STEROID EYE DROP EFFECT THAT BEGAN TO APPLY THE PREVIOUS TIME. VA AFFECT: NONE CORRECTED VA OD: 1.0¿. THE PRODUCT AVAILABILITY AND LOT # IS UNKNOWN. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2015 OUR AFFILIATE IN (B)(4) REPORTED THAT DURING A CONTACT LENS SOCIETY CONFERENCE, AN EYE CARE PROFESSIONAL (ECP) PRESENTED A CASE INVOLVING (B)(6) DEFINE CONTACT LENS (CL) AS FOLLOWS: ¿A FEMALE WORE (B)(6) DEFINE LENS FOR MORE THAN A MONTH. THE PT VISITED TO THE DOCTOR BECAUSE OF PERSISTING PAIN (AFFECTED EYE UNKNOWN) FROM THE DAY BEFORE. THE ECP ADVISED THAT THE SYMPTOM THAT OCCURRED WITHIN A MONTH INDICATED THE POSSIBILITY OF PSEUDOMONAL INFECTION.¿ THE PT WAS IMMEDIATELY REFERRED TO AN ECP FOR TREATMENT. ON (B)(6) 2015 OUR AFFILIATE IN (B)(4) SENT AN E-MAIL TO THE PT¿S ECP AND REQUESTED ADDITIONAL INFORMATION. ON (B)(6) 2015 OUR AFFILIATE RECEIVED AN E-MAIL FROM THE ECP WHO ADVISED THAT THE ¿PT IS IN TREATMENT AND RESPONDS TO MEDICAL THERAPY. THE NEXT CONSULTATION SEEMS TO BE IN 2-3 WEEKS. FOR THESE REASONS, THE DOCTOR SUGGESTED (B)(6) 2015 AT 17:00 AS A DATE OF FACE-TO-FACE INTERVIEW.¿ ON (B)(6) 2015 THE DOCTOR WAS NOT AT THE OFFICE. THE APPOINTMENT IS RESCHEDULED FOR (B)(6) 2015. THE LOT NUMBER OF THE SUSPECT PRODUCT IS UNKNOWN AND THE PRODUCT AVAILABILITY IS UNKNOWN AT THIS TIME. 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
    500474 ACUVUE2 DEFINE LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-A2D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R