BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON-A

    MDR report key: 1851190 · Received September 30, 2010

    Report

    Report Number
    1033553-2010-00079
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 30, 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

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PT'S MOTHER CALLED OUR (B)(4) AFFILIATE ON (B)(6)2010 TO REPORT THE PT EXPERIENCED PAIN WHILE INSERTING A 1-DAY ACUVUE TRUEYE LENS. THE PT WAS SEEN AT A CLINIC ON (B)(6)2010 AND WAS TOLD THAT THE PT HAD CORNEAL STAINING OD AND THE OD WAS "INFECTED." THE PT PRESCRIBED MEDICATION WAS INSTRUCTED TO DISCONTINUE CONTACT LENS WEAR UNTIL THE PT RECOVERS AND TO RETURN TO THE CLINIC IN ONE WEEK. THE EYE CLINIC WAS CONTACTED ON 09/07/2010 FOR INFO REGARDING THIS EVENT. THE CLINIC REPORTED THE PT WAS DIAGNOSED WITH A CORNEAL ULCER OD (B)(6)2010. THE ULCER WAS PERIPHERAL AND ABOUT 1 MM IN DIAMETER. THE PT WAS TREATED WITH CRAVIT AND BESTRON EYE DROPS AND TARIVID OPHTHALMIC OINTMENT. THE PT RETURNED TO THE CLINIC ON (B)(6)2010 AND THE SYMPTOM HAD IMPROVED. THE PT WAS INSTRUCTED TO DISCONTINUED CONTACT LENS WEAR FOR THE WEEK AND RESUME CONTACT LENS WEAR THE FOLLOWING WEEK AND ANOTHER FOLLOW-UP VISIT WOULD BE UNNECESSARY IF THE PT RECOVERS. THE EVENT WAS NOT CONSIDERED SERIOUS. A FACE TO FACE MEDICAL INTERVIEW WAS SCHEDULED FOR (B)(6)2010. OUR (B)(4) AFFILIATE CONTACTED THE PT'S MOTHER ON (B)(6)2010, SHE REPORTED THE PT STILL HAS EYE PAIN AND THE PT IS CONSIDERING CONSULTING ANOTHER ECP. NO ADDITIONAL INFO HAS BEEN RECEIVED AT THIS TIME. THE PRODUCT IN QUESTION IS NOT AVAILABLE FOR EVAL. A 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. THE LOT WAS PRODUCED UNDER NORMAL CONDITIONS. THERE HAVE BEEN NO SIMILAR COMPLAINTS ASSOCIATED WITH THIS LOT. A CORNEAL ULCER MAY OR MAY NOT BE A SERIOUS INJURY. BASED ON THE LIMITED INFO RECEIVED, THIS INJURY WILL BE REPORTED AS A SERIOUS INJURY AS A WORST CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE TRUEYE NARAFILCON-A SOFT CONTACT LENS LPL VISTAKON NA 5311051109

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other