BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON-A

    MDR report key: 1843558 · Received September 22, 2010

    Report

    Report Number
    1033553-2010-00071
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 22, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION WAS NOT AVAILABLE FOR EVALUATION. THE LOT HISTORY REVIEW REVEALED 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. INFORMATION RECEIVED FROM COMPLAINANT WAS LIMITED AND SUGGESTED POTENTIAL SERIOUS INJURY AND IS BEING REPORTED AS WORST CASE. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS. LABELED FOR SINGLE USE. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    OUR (B)(4) AFFILIATE RECEIVED INFORMATION FROM A PT INDICATING THE PT EXPERIENCED ACUTE PAIN OS WHILE WEARING 1-DAY ACUVUE TRUEYE LENSES. THE PT REPORTED A BURNING PAIN UPON INSERTING THE LENS INTO THE OS. THE PT SAID IT TOOK 10 DAYS FOR THE SYMPTOMS TO RESOLVE. OUR AFFILIATE CONTACTED THE TREATING EYE CLINIC AND LEARNED THAT ON THE MORNING OF (B)(6)2010 THE PT EXPERIENCED BURNING PAIN, INJECTION AND TEARING OS. THE PT WAS DIAGNOSED WITH A "CORNEAL ULCER" OS AND WAS PRESCRIBED CRAVIT AND HALONSAN EYE DROPS AND KYORINN AP-2 FOR PAIN. ON (B)(6)2010, THE PT WAS CONTACTED AND SAID THE OS WAS IMPROVING AND THE TREATMENT WOULD BE COMPLETED ON (B)(6)2010. THE EYE CLINIC WAS CONTACTED ON (B)(6)2010 AND A STAFF MEMBER SAID THE PT HAD RETURNED FOR FOLLOW-UP ON (B)(6)2010 AND THE PAIN HAD SUBSIDED AND CORNEAL STAINING HAD IMPROVED. THE PT WAS INSTRUCTED TO FINISH THE MEDICATIONS. IT WAS NOTED THAT THE "ULCER" WAS 12 MM IN DIAMETER. THE LESION WAS NOT THOUGHT TO BE INFECTED AND WAS NOT CULTURED. ON (B)(6)2010, THE PT WAS CONTACTED AND REPORTED THAT HE/SHE HAD TO TAKE "COMPLETE REST FOR 2 DAYS" AND THE PT'S EYE WAS PATCHED FOR 4 DAYS. A MEETING WITH THE TREATING ECP IS SCHEDULED FOR (B)(6)2010. BASED UPON THE LIMITED INFORMATION, RECEIVED, WE DO NOT BELIEVE THIS INJURY IS A CORNEAL ULCER, BUT A CORNEAL EROSION OR ABRASION. A MEETING WITH THE TREATING ECP IS SCHEDULED FOR (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE TRUEYE NARAFILCON-A SOFT CONTACT LENS LPL VISTAKON NA 4922660601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other