BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS BRAND

    MDR report key: 4142868 · Received September 23, 2014

    Report

    Report Number
    1033553-2014-00087
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 23, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPEN BLISTER AND THREE SEALED BLISTERS WERE RECEIVED. THE SUSPECT LENS WAS RETURNED. THE PARAMETERS OF THE SUSPECT LENS WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENS MET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. ON VISUAL INSPECTION THE SUSPECT LENS HAD AN EDGE CHIP. NO OTHER VISUAL ATTRIBUTES WERE OBSERVED. THREE SEALED BLISTERS WERE ALSO RECEIVED FROM LOT #L0028NQ. THE SOLUTION WAS ALSO TESTED. THE PH WAS IN SPECIFICATION. THERE WAS NOT ENOUGH SOLUTION TO MEASURE CONDUCTIVITY. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE BATCH DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. ANY ADDITIONAL INFO RECEIVED WITH 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) 2014, OUR FIRM RECEIVED A CALL FROM A PATIENT (PT) REPORTING THAT HE/SHE HAD PAIN AFTER THE REMOVAL OF A TORN ACUVUE OASYS CONTACT LENS (CL) ON DAY 2 OF THE WEAR CYCLE. ON (B)(6) 2014, THE PT CALLED TO REPORT ADDITIONAL INFO. THE PT STATES THAT HE/SHE UNDERWENT CORNEAL CURETTAGE. ON (B)(6) 2014, THE EYE CLINIC WAS CONTACTED FOR A MEDICAL INTERVIEW AND THE FOLLOWING INFO WAS PROVIDED. "ON (B)(6) 2014, THE PT WAS INITIALLY SEEN AT THE CLINIC. THE PT WAS DIAGNOSED WITH CORNEAL ULCER OD. THE PT'S OS WAS FINE. THE ULCER WAS 1-2MM IN SIZE AND LOCATED AT 4 O'CLOCK. THE PT'S CORRECTED VA OD WAS 1.2 AND NOT AFFECTED. THE ULCER WAS INFECTIOUS. NO CULTURES WERE PERFORMED. THE PT WAS PRESCRIBED CRAVIT 1.5% EYE DROPS QID FOR OD, TOSUFLOXACIN (ANTIBIOTIC) AND MUCOSTA (STOMACH MEDICINE) ORAL MEDICINE TID X 5 DAYS, CALONAL (PAIN RELIEVER) ORAL MEDICINE PRN PAIN X 3 DAYS. THE PT WAS INSTRUCTED TO RETURN FOR FOLLOW-UP IN TWO DAYS AND TO DISCONTINUE CL WEAR UNTIL THEN. ON (B)(6) 2014, THE PT RETURNED TO THE CLINIC. THE PT UNDERWENT CORNEAL CURETTAGE OD. THE PT WAS PRESCRIBED NIFLAN 0.1% EYE DROPS QID FOR OD, TOSUFLOXACIN (ANTIBIOTIC) AND MUCOSTA (STOMACH MEDICINE) ORAL MEDICINE TID X 5 DAYS. THE PT WAS INSTRUCTED TO CONTINUE TO APPLY CRAVIT 1.5%. THE PT WAS NOT GIVEN CALONAL BECAUSE THE PT STILL HAD SOME". ON (B)(6) 2014, THE EYE CLINIC WAS CONTACTED FOR A MEDICAL INTERVIEW AND THE FOLLOWING INFO WAS PROVIDED. THE NURSE STATED THAT THE ULCER WAS LOCATED AT THE PERIPHERAL CORNEA NEAR THE CORNEAL LIMBUS AND THE PUPIL WAS NOT AFFECTED. THE CALL WAS TRANSFERRED TO THE ECP WHO PROVIDED ADDITIONAL INFO. "ON (B)(6) 2014, THE PT RETURNED TO THE CLINIC. THE ULCER WAS IMPROVING. THE PT WAS INSTRUCTED TO DISCONTINUE CL WEAR UNTIL FULL RECOVERY, BUT THE PT WAS ALLOWED TO WEAR CLS AS LONG AS IT IS FEW HOURS' CL WEAR ONLY WHEN NEEDED. THE PT WAS INSTRUCTED TO CONTINUE TO APPLY THE REMAINING PRESCRIPTION EYE DROPS. THE ECP DETERMINED THAT THE SERIOUSNESS OF THE EVENT WAS BETWEEN MILD AND MODERATE AND IT UNK WHETHER THIS EVENT WAS CL-RELATED. THE ECP NOTED FOREIGN MATTER BURIED IN THE CENTER OF ULCER. THE ECP PRESUMED THAT THE PT GOT SMALL FOREIGN MATTER BETWEEN OD AND CL, WHICH CAUSED THE STAINING OD, AND THE FOREIGN MATTER WAS BURIED THERE, THEN MICROBIAL INFECTION DEVELOPED AT THE PART. THE ECP THINKS THAT THIS EVENT OCCURRED WHETHER OR NOT THE CL IN QUESTION WAS TORN". ON (B)(6) 2014, THE PT CALLED TO REPORT ADDITIONAL INFO AS FOLLOWS. "THE PT WAS ALLOWED TO WEAR CLS AFTER FOREIGN MATTER WAS REMOVED FROM OD". THE PT HAS NOT RETURNED TO THE CLINIC SINCE THE (B)(6). THE PT ADVISED THAT HE/SHE WEARS CLS AND EYE GLASSES ALTERNATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590978 ACUVUE OASYS BRAND SOFT CONTACT LENS LPL VISTAKON NA L0028NQ

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention