BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS FOR ASTIGMATISM

    MDR report key: 3687472 · Received March 10, 2014

    Report

    Report Number
    1033553-2014-00026
    Event Type
    Injury
    Date Received
    March 10, 2014
    Date of Event
    February 7, 2014
    Report Date
    March 10, 2014
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP .

    Description of Event or Problem · 1

    ON (B)(6) 2013, A PATIENT'S DAD CONTACTED OUR FIRM REPORTING A PRODUCT QUALITY ISSUE AND WAS SEEKING REPLACEMENT CONTACT LENSES (CL) AND HIS DAUGHTER EXPERIENCED "A SERIOUS EYE INFECTION" AND "ULCER" FOR WHICH SHE RECEIVED AGGRESSIVE ANTIBIOTIC TREATMENT. OUR FIRM SPOKE WITH THE TREATING EYE CARE PROFESSIONAL'S OFFICE AND WAS TOLD THE PT'S ISSUE WAS RELATED TO IMPROPERLY CARING FOR AND OVER-WEARING CL. THE FOLLOWING WAS REPORTED: ON (B)(6) 2014 - PT PRESENTED TO THE DOCTOR'S OFFICE FOR THE FIRST TIME, C/O OD PAIN PHOTOPHOBIA AND REDNESS THAT STARTED ON (B)(6) 2014. SHE REPORTED HAVING REMOVED THE CL IMMEDIATELY AND SELF TREATING WITH TOBRAMYCIN "PINK EYE DROPS" FOUR TIMES A DAY. SLE REVEALED INFLAMMATION, 2+ CELLS, A CU SUPERIORLY LOCATED AND INFILTRATES. CYCLOGEL WAS USED TO DILATE THE PUPIL. THE TREATMENT REGIMEN INCLUDED BESIVANCE QHR, THEN Q2HRS ON (B)(6) 2014 AND CILOXAN GEL QHS; THE PT WAS INSTRUCTED NOT TO WEAR CL. ON (B)(6) 2014 - THE PT RETURNED FEELING BETTER AND THE ULCER AND PHOTOPHOBIA WERE BETTER. SLE REVEALED DECREASE IN CELLS AND INFLAMMATION; CYCLOGEL WAS INSTILLED TO DILATE THE PUPIL; PREDNISONE FORTE BID ADDED. ON (B)(6) 2014 - PT RETURNED, NO LIGHT SENSITIVITY, AND SLIGHT DISCOMFORT. SLE REVEALED DECREASED REDNESS AND FADING INFILTRATE, BESIVANCE DECREASED TO QUID. PRED FORTE INCREASED TO QID, CILOXAN CONTINUED. ON (B)(6) 2014 - PT RETURNED NO PAIN OR PHOTOPHOBIA. SLE REVEALED A FADED INACTIVE CORNEAL INFILTRATE, SMALL SCAR SUPERIORLY OUT OF VISUAL AXIS AND REDNESS SUBSIDED. PT INSTRUCTED NOT TO WEAR CL UNTIL CLEARED BY THE PRESCRIBING ECP. ON (B)(6) 2014 - THE PRESCRIBING ECP'S OFFICE STATED THE PT WAS SEEN (B)(6) 2014 AND CLEARED TO RESUME CL WEAR. THE PT WAS ON A 2 WK. REPLACEMENT SCHEDULE; THE WEAR SCHEDULE WAS UNKNOWN. PROD. HAS BEEN DISCARDED BY THE PT. LOT B00FZ4L WAS PLACED ON HOLD FOR PACKAGE INTEGRITY TESTING. IT WAS RELEASED AFTER ALL TESTING REQUIREMENTS WERE COMPLETE AND MET THE REQUIREMENTS OF THE PROTOCOL. 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. NO ADDITIONAL INFORMATION IS EXPECTED. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143319 ACUVUE OASYS FOR ASTIGMATISM DISPOSABLE SOFT CONTACT LENS LPL VISTAKON NA B00FZ4L

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other| R OPTI FREE PURE MOIST