BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY TRUEYE CONTACT LENSES NARAFILCON A

    MDR report key: 2210695 · Received August 8, 2011

    Report

    Report Number
    1033553-2011-00053
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 8, 2011
    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

    ON (B)(6) 2011, A PT CONTACTED OUR (B)(4) AFFILIATE TO REPORT THE PT PURCHASED 1-DAY ACUVUE TRUEYE CONTACT LENSES (NARAFILCON A) ABOUT 1 MONTH PRIOR TO THE CALL AND ONLY WORE THOSE LENSES IN THE RIGHT EYE (OD). NARAFILCON-A CONTACT LENSES ARE NOT MARKETED IN THE US. THE PT WORE 1-DAY ACUVUE MOIST CONTACT LENSES IN THE LEFT EYE (OS). THE PT SAID THAT ON (B)(6) 2011, THE PT EXPERIENCED ACUTE PAIN AND DEVELOPED REDNESS, AND GLARE OD. THE PT SAID HE/SHE REMOVED THE LENS IN QUESTION. ON (B)(6) 2011, THE PT VISITED AN EYE CLINIC AND WAS TOLD HIS/HER CORNEA WAS "DAMAGED" AND THE PT WAS DIAGNOSED WITH IRITIS. THE PT WAS INSTRUCTED TO RETURN TO THE CLINIC (RTC) ON (B)(6) 2011, DISCONTINUE CONTACT LENS (CL) WEAR FOR 1 MONTH AND WAS GIVEN THREE PRESCRIPTION EYE DROPS AND ONE PRESCRIPTION EYE OINTMENT. THE PT SAID HIS/HER OD WAS STILL RED AT THE TIME OF THE CALL. THE PT HAD PRODUCT TO RETURN FOR EVAL. OUR (B)(4) AFFILIATE REQUESTED THE PT'S CONSENT TO CONTACT HIS/HER EYE CARE PROFESSIONAL FOR MED INFO PERTAINING TO THE EVENT AND THE PT INITIALLY AGREED. ON (B)(6) 2011, THE TREATING EYE CLINIC WAS CONTACTED FOR INFO, THE CLINIC COULD NOT RELEASE INFO WITHOUT WRITTEN CONSENT FROM THE PT. ON (B)(6) 2011, THE PT WAS CONTACTED AND SAID HIS/HER OD WAS IMPROVING AND THE PT WAS INSTRUCTED TO RTC ON (B)(6) 2011. ON (B)(6) 2011, A WRITTEN CONSENT FORM WAS SENT TO THE PT VIA EXPRESS COURIER. ON (B)(6) 2011, THE CLINIC WAS CONTACTED FOR INFO AND THEY HAD NOT REC'D PT'S WRITTEN CONSENT FORM. ON (B)(6) 2011, THE PT WAS CONTACTED AND PROVIDED INFO FROM A RECEIPT FROM THE ECP. "DIAGNOSIS RECEIPT OF (B)(6)2011; TREATMENT: SLIT-LAMP MICROSCOPE EXAMINATION (ANTERIOR EYE). FUNDUSCOPY OU, EXAMINATION FOR CORRECTED VA, REFRACTION TEST; CORNEAL DIAMETER GAUGING, EYE PRESSURE MEASUREMENT, CHROMOSOMAL TEST. MEDICATION GATIFLOXACIN OPHTHALMIC SOLUTION 0.3%, TOSUFLO, 0.3%, TARVID EYE OINTMENT 0.3%, MYDRIN-P." THE DIAGNOSIS RECEIPT FOR (B)(6) 2011 STATED, "TREATMENT: SLIT-LAM MICROSCOPE EXAMINATION (ANTERIOR EYE). EYE PRESSURE MEASUREMENT (THE PT WAS ON STEROIDS). MEDICATION: FLUMETHOLON 0.1%. ON (B)(6) 2011, THE PT CONTACTED OUR (B)(4) AFFILIATE; THE PT SAID HIS/HER CONDITION HAD GREATLY IMPROVED. THE PT WAS WEARING CONTACT LENSES AT THE TIME OF THE CALL. THE PT SAID HE/SHE WAS NOT SATISFIED WITH TREATMENT AT THE INITIAL CLINIC AND THE PT SOUGHT TREATMENT AT ANOTHER CLINIC WHERE THE PT HAD REC'D EYE CARE IN THE PAST, THE PT DID NOT PROVIDE US WITH THE NAME OF THE CLINIC. THE PT SAID THAT THE SECOND ECP SAID THE IRITIS WAS "TRAUMATIC". THE PT WAS CONTINUING TO USE EYE MEDICATIONS, THE NAMES OF THOSE MEDICATIONS WERE NOT PROVIDED. THE PT REFUSED TO PROVIDE US WITH ADD'L INFO. THE PRODUCT WAS REQUESTED BUT HAS NOT BEEN REC'D FOR EVAL. A LOT HISTORY REVIEW WAS PERFORMED AND 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. LOT 5205331492 WAS PRODUCED UNDER NORMAL CONDITIONS. IF ADD'L MED OR PRODUCT INFO IS REC'D, WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY TRUEYE CONTACT LENSES NARAFILCON A SOFT CONTACT LENS LPL VISTAKON NA 5205331492

    Patients

    Seq Age Sex Outcome Treatment
    1 Other