BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND COLOURS CONTACT LENSES

    MDR report key: 3201430 · Received June 28, 2013

    Report

    Report Number
    1033553-2013-00081
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    November 1, 2011
    Report Date
    June 28, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED ADDITIONAL INFORMATION FROM AMO. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL MEDICAL OR PRODUCT INFORMATION IS RECEIVED, WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION FOUND ON A SEARCH OF THE MAUDE DATABASE ON (B)(4) 2013 FOR THE PERIOD (B)(6) 2011 THROUGH (B)(6) 2013. THIS INFORMATION WAS REPORTED TO THE FDA ON (B)(4) 2011 BT ABBOTT MEDICAL OPTICS. AMO'S MDR #: 2020664-2011-00128. WE RECEIVED MEDICAL RECORDS REGARDING A (B) (6) FEMALE PATIENT WHO EXPERIENCED ACANTHAMOEBA KERATITIS WHILE USING AN EXPIRED BOTTLE OF COMPLETE MULTIPURPOSE SOLUTION EASY RUB WITH HER ACUVUE 2 COLORS SOFT CONTACT LENSES. ON (B) (6) 2011, ONSET OF SYMPTOMS IN THE RIGHT EYE (OD) INCLUDED REDNESS AND A FOREIGN BODY SENSATION; INITIAL DIAGNOSIS WAS CORNEAL ABRASION VS (B) (6). SHE IS TREATED WITH GANCICLOVIR AND THERE IS NO IMPROVEMENT; SHE REFERRED TO A SPECIALIST. TREATMENT CONTINUES AND BY (B) (6) 2011 STROMAL RADIAL PERINEURITIS AND DENDRIFORM EPITHELIAL LESION ARE OBSERVED. CONFOCAL MICROSCOPY IS POSITIVE FOR ONE DOUBLE-WALLED CYST CONSISTENT WITH ACANTHAMOEBA. CORNEAL SCRAPING IS POSITIVE FOR COAGULASE NEGATIVE (B)(6). THE CONTACT LENS CASE WAS POSITIVE FOR ENTEROBACTER CLOACAE AND SPHINGOBACTERIUM MULTIVORUM. TREATMENT CONTINUES THROUGH (B) (6) 2011 WHERE NOTES SHOW UNCONTROLLED MICROBIAL KERATITIS; A PENETRATING KERATOPLASTY IS PERFORMED. ONE DAY POST-OP INTRAOCULAR PRESSURE (IOP) IS INCREASED TO 34 AND 36 MMHG. MICROSCOPIC EVALUATION OF THE CORNEAL BUTTON IS POSITIVE FOR ACANTHAMOEBA. CHLORHEXIDINE IS ADDED TO TREATMENT AS WELL AS COMBIGAN, LUMIGAN AND ACETAZOLAMIDE. CHLORHEXIDINE IS DISCONTINUED (B) (6) 2011. PATIENT'S RIGHT-SIDED HEADACHES ARE ATTRIBUTED TO INCREASED IOP. ON (B) (6) 2011, VA OD IS 20/100 PINHOLE TO 20/40. LYSIS OF IRIS ADHESIONS IS PERFORMED. ON (B) (6) 2011, IO IS 46 MMHG. SHE CONTINUES TREATMENT FOR INCREASED IOP WHERE IRIDOCORNEAL ADHESION ARE NOTED IN ALL FOUR QUADRANTS; A GLAUCOMA SHUNT IS SCHEDULED FOR (B) (6) 2011. OTHER MEDICATIONS DURING TREATMENT: DIAMOX, VANCOMYCIN, ZYMAXID, ZIRGAN, LOTEMAX, ZYLET, PRED FORTE, VIGAMOX, GENTAMYCIN, ATROPINE, VORICONAZOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296379 ACUVUE 2 BRAND COLOURS CONTACT LENSES SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R EXPIRED COMPLETE MULTIPURPOSE EASY RUB SOLUTION