BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUVUE ADVANCE

    MDR report key: 930504 · Received October 19, 2007

    Report

    Report Number
    1033553-2007-00107
    Event Type
    Injury
    Date Received
    October 19, 2007
    Date of Event
    August 31, 2007
    Report Date
    October 19, 2007
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACUVUE ADVANCE FOR ASTIGMATISM: DEVICE LABELING FOR REUSE. ACUVUE TORIC: DEVICE LABELING FOR SINGLE USE OR REUSE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM OUR ANOTHER COUNTRY AFFILIATE. AN OPHTHALMOLOGIST REPORTED, A PT HAD TWO CORNEAL ULCERS IN THE OS, ONE PERIPHERAL AND ONE PARACENTRAL. THE DOCTOR REPORTED PUS WAS OBSERVED AND THE ULCERS WERE CONSIDERED BACTERIAL. THE ULCERS WERE NOT CULTURED. THE PATIENT WAS TREATED WITH CEBEMYXINE AND CYLOXAN EVERY HOUR. THREE DAYS FOLLOWING THE START OF TREATMENT THE CORNEAL ULCERS WERE REPORTEDLY REGRESSING. VISUAL ACUITY WAS 6/10(-20/35). IN 2007, WE LEARNED THE CORNEAL ULCER HAD HEALED, MEDICATION WAS DISCONTINUED AND THE PT HAS A PARACENTRAL SCAR. THE PT'S VA REMAINS 6/10 DUE TO THE PARACENTRAL SCAR. THE DOCTOR REPORTED THE PATIENT HAD BEEN WEARING ACUVUE ADVANCE FOR ASTIGMATISM CONTACT LENSES ON A DAILY WEAR SCHEDULE AND THE PATIENT REPORTEDLY HAS A HISTORY OF GOOD HYGIENE AND WAS COMPLIANT WITH LENS CARE AND FREQUENCY OF LENS REPLACEMENT. THE LENS CARE SOLUTION USED BY THE PT WAS A SAMPLE OF GRAND OPTICAL, A PRIVATE LABEL SOLUTION, MANUFACTURED BY AMO. THE PRODUCT IN QUESTION WAS REQUESTED FOR EVALUATION. THE DOCTOR RETURNED AN OPENED 6 LENS MULTIPACK CARTON OF ACUVUE ADVANCE FOR ASTIGMATISM LENSES (510K: K032340) FROM LOT B003GB2, MANUFACTURED 05/2005 WITH AN EXPIRATION DATE OF 05/2011. THE OPEN CARTON CONTAINED 2 SEALED BLISTERS OF ACUVUE TORIC BRAND CONTACT LENSES (PMA: N18033) FROM LOT B0010FS, MANUFACTURED 08/2002 WITH AN EXPIRATION DATE OF 08/2007 (THIS PRODUCT WAS EXPIRED). OUR ANOTHER COUNTRY AFFILIATE CONTACTED THE DOCTOR WHO REPORTED HE HAD NOT PREVIOUSLY TREATED THIS PT. THE DOCTOR PROVIDED THE FOLLOWING INFORMATION: THE PT HAD WORN ACUVUE TORIC LENSES FROM 2001 UNTIL THE END OF 2006. THE PT'S OPTICIAN SWITCHED THE PT TO ACUVUE ADVANCE FOR ASTIGMATISM IN 2007. THE DOCTOR COULD NOT TELL US WITH CERTAINTY WHICH LENS WAS WORN BY THE PT. WE THEREFORE INVESTIGATED BOTH PRODUCTS. THE RETURNED ACUVUE TORIC LENSES WERE EVALUATED AND THE RESULTS ARE AS FOLLOWS: TWO SEALED BLISTERS WERE RETURNED. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR DIAMETER, BASE CURVE AND CENTER THICKNESS. NO VISUAL ATTRIBUTES WERE OBSERVED. THERE WAS NOT ENOUGH SOLUTION TO TEST FOR PH AND CONDUCTIVITY. A LOT HISTORY REVIEW WAS PERFORMED FOR BOTH LOTS, THE RESULTS ARE AS FOLLOWS FOR BOTH LOTS: THE BATCH RECORDS DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. A REVIEW OF OUR WORLDWIDE COMPLAINT DATABASE REVEALS THERE ARE NO OTHER REPORTS OF ADVERSE REACTION FOR EITHER LOT. ALL MDR REPORTABLE EVENTS ARE REVIEWED AT QUARTERLY MANAGEMENT REVIEW MEETINGS. WE DO NOT EXPECT TO RECEIVE ANY ADDITIONAL INFORMATION FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUVUE ADVANCE SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability