BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE CLEAR BRAND

    MDR report key: 2992510 · Received March 4, 2013

    Report

    Report Number
    1033553-2013-00017
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    March 1, 2012
    Report Date
    March 4, 2013
    Product Code
    LPM
    PMA / PMN Number
    N18033
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT PRODUCT IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY REVIEW WAS PERFORMED. LOT 3532180103 WAS PRODUCED UNDER NORMAL MFG CONDITIONS. THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. IF ADDITIONAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENTS AND TRENDS ARE REVIEWED IN QUARTERLY FRANCHISE MGMT REVIEW MEETINGS. DEVICE LABELING SINGLE REUSE. NO CONCLUSION CAN BE DRAWN. DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    INFO RECEIVED FROM OUR (B)(4) AFFILIATE. THIS INFO INDICATES A PATIENT (PT) EXPERIENCED ACANTHAMOEBA OD WHILE WEARING ACUVUE CLEAR CONTACT LENSES (CL). THE PT WORE THE LENSES ON A DAILY WEAR AND BIWEEKLY REPLACEMENT SCHEDULE. THE PT USED RENU MULTI-PURPOSE SOLUTION TO CLEAN/DISINFECT LENSES. OUR AFFILIATE REPORTED THE FOLLOWING : THE PT USED ACUVUE CLEAR FOR THE FIRST TIME WITHOUT BEING FIT IN THE LENSES. THE PT EXPERIENCED REDNESS AND PAIN OD. THE INJURY OCCURRED IN (B)(6) 2012, ON (B)(6) 2012, THE PT CONSULTED AN EYE CARE PROFESSIONAL (ECP) AND WAS DIAGNOSED WITH "CORNEAL EDEMA CAUSED BY ACANTHAMOEBA" OD. THE PT WAS PRESCRIBED "ZYMAR 1 DROP EACH 2 HRS (PT YET IS USING), PREDIFFORT 2 DROPS EACH 2 HRS (USED BY 1 DAY), MEDNICYL 1 DROP EACH 8 HRS (USED BY 1 DAY), VIGADEXA 1 DROP EACH 4 HRS (USED BY 45 DAYS)". NO OTHER DATES OF SERVICE PROVIDED. THE REPORT STATED THAT THE PT EXPERIENCED PERMANENT DAMAGE OR PERMANENT LOSS OF VISUAL ACUITY; THE VISUAL ACUITY WAS NOT PROVIDED. THE PT WAS "WITHOUT VISION ON OD". NUMEROUS UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO COLLECT ADDITIONAL CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90721 ACUVUE CLEAR BRAND SOFT CONTACT LENSES LPM NA 3532180103

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other RENU MULTIPURPOSE LENS CARE SOLUTION