BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE ADVANCE WITH HYDRACLEAR

    MDR report key: 1221214 · Received November 5, 2008

    Report

    Report Number
    1033553-2008-00131
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 8, 2008
    Report Date
    November 5, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM OUR AFFILIATE INDICATES A PT DEVELOPED CORNEAL ABRASIONS OU WHILE WEARING ACUVUE ADVANCE CONTACT LENSES. THIS REPORT IS FOR THE PTS OS THE PT HAD A PROBLEM WITH DRY EYES AND HAD BEEN USING OTC PRESERVATIVE FREE EYE DROPS MORE FREQUENTLY SINCE SWITCHING TO ACUVUE ADVANCE. THREE TO 5 DAYS AFTER INITIALLY WEARING ACUVUE ADVANCE CONTACT LENSES, THE PT HAD A FOREIGN BODY SENSATION OD, WHEN THE LENSES WERE REMOVED, THE PT'S EYE TURNED RED. THE PT SAW HIS/HER EYE CARE PROFESSIONAL (ECP) AND EYE DROPS AND ORAL MEDICATIONS WERE PRESCRIBED. THE PT REPORTED THE CORNEAL ABRASION APPEARED TO BE HEALED IN ABOUT 1 WEEK AND THE PT RESUMED LENS WEAR AND HIS/HER EYE BEGAN GETTING RED AGAIN AND THE PT DEVELOPED SIMILAR SYMPTOMS IN THE OS. THE PT STOPPED WEARING LENSES. WE CONTACTED THE PT'S ECP FOR ADDITIONAL INFORMATION, BUT THE ECP INITIALLY REFUSED TO PROVIDE ANY INFORMATION. THE PT TOLD US THE ECP PRESCRIBED CRAVIT, BESTRON, TARIVID EYE DROPS, AND CEFCAPENE PIVOXIL HCL ORAL MEDICATION UPON THE INITIAL CONSULTATION. THE ECP PROVIDED THE FOLLOWING INFORMATION ON 10/17/08: THE PT WAS DIAGNOSED WITH A CORNEAL ULCER OS ON THE PREVIOUS MONTH, AND A CORNEAL ULCER OD ON THE ORIGINAL MONTH. BOTH ULCERS WERE LOCATED IN THE MID-PERIPHERAL CORNEA. THE ECP DID NOT MEASURE THE ULCERS, THE ECP NOTED THEY DID NOT AFFECT THE PT'S VA. IT WAS ALSO REPORTED THAT THE PT HAD IRITIS OU. THE EMPIRICAL DIAGNOSIS WAS THAT THE ULCERS WERE INFECTIOUS. ON ORIGINAL DATE, THE PT RETURNED TO THE CLINIC AND HAD PUNCTUATE CORNEAL INFILTRATION OU, NOT IN THE AREAS OF THE CORNEAL ULCERS. THE ECP DID NOT KNOW THE CAUSE OF THE ULCERS. THE ECP DID NOT PRESCRIBE THE LENSES IN QUESTION AND THE PT DID NOT FOLLOW-UP AS INSTRUCTED. OUR AFFILIATE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE ECP. ON THREE DAYS LATER, THE PT TOLD US HE/SHE WAS SUCCESSFULLY WEARING ACUVUE 2 LENSES PRESCRIBED BY ANOTHER ECP. FIVE SEALED BLISTERS WERE AND A LENS CASE WERE RETURNED. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO VISUAL ATTRIBUTES WERE OBSERVED. THE SOLUTION WAS ALSO TESTED. THE PH AND CONDUCTIVITY WERE IN SPECIFICATION. THE DEVICE HISTORY RECORD FOUND THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE ADVANCE WITH HYDRACLEAR SOFT CONTACT LENS LPL VISTAKON NA B005B95

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other