BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS FOR ASTIGMATISM CONTACT LENSES

    MDR report key: 3810164 · Received April 30, 2014

    Report

    Report Number
    1033553-2014-00037
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 30, 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

    DEVICE LABELING: SINGLE USE OR REUSE. BASED ON ALL AVAILABLE INFO, NO CASUAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. IF ADD'L PRODUCT OR MEDICAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    A PT CONTACTED OUT (B)(4) AFFILIATE ON (B)(6) 2014, THE PT HAD PAIN OS WHEN INSERTING FRESH NEW ACUVUE OASYS FOR ASTIGMATISM CONTACT LENS. THE PT NOTICED THAT THE CONTACT LENS (CL) WAS TORN UPON REMOVAL. THE PT HAS PAIN OS FOLLOWING CL REMOVAL AND HAD DISCOMFORT OS AT THE MOMENT. THE PT HAD CONSULTED AN EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2014 AND WAS DIAGNOSED WITH "SMALL STAINING OS." THE PT WAS INSTRUCTED TO DISCONTINUE CL WEAR FOR THE REST OF THE DAY AND WAS PRESCRIBED HYALANSAN 0.1% EYE DROPS AND RETURN FOR FOLLOW-UP IF THE SYMPTOMS DO NOT IMPROVE. THE PT SAID SHE WOULD CONTACT OUT AFFILIATE IF THE SYMPTOMS PERSIST. OUR AFFILIATE REQUESTED THE PT RETURN ALL THE CL'S WHICH ARE AVAILABLE, BUT THE PT SAID THAT SHE NEEDS TO USE THE CL'S. THE CL IN QUESTION WILL BE RETURNED TO US, BUT IT US UNK IF LENSES, OTHER THAN THE CL IN QUESTION, WILL BE RETURNED. ON (B)(6) 2014 THE PT CALLED AND REPORTED A "STRONG PAIN" OS WHEN INSERTING AN ACUVUE OASYS FOR ASTIGMATISM CONTACT LENS. THE PT REPORTEDLY COULD NOT WEAR CL'S DUE TO THE PAIN. THE PT CONSULTED A DIFFERENT ECP ON (B)(6) 2014 AND WAS DIAGNOSED WITH "DEEP STAINING OS." THE PT WAS INSTRUCTED TO DISCONTINUE CL WEAR UNTIL THE OS FULLY RECOVERED AND WAS PRESCRIBED CRAVIT AND RIZABEN EYE DROPS. THE PT AGREED TO ALLOW OUR AFFILIATE TO CONTACT THE 2ND ECP. THE PT WAS CONTACTED ON (B)(6) 2014 AND REPORTED FEELING BETTER BUT STILL HAD A FOREIGN BODY SENSATION (FBS) OS WHEN LOOKING UPWARD AND SWELLING IN THE UPPER EYELID OS. THE PT'S ECP TOLD THE PT SHE HAD SWELLING IN THE UPPER EYELID OS AND THAT THE PT MIGHT HAVE STAINING THERE. THE PT WILL RETURN TO THE SECOND ECP'S CLINIC ON (B)(6) 2014. THE PT WORE EYE GLASSES AT THE MOMENT. ON (B)(6) 2014, THE PT WAS CONTACTED AND PROVIDED THE FOLLOWING INFO: THE PT HAD STRONG FBS OS ON (B)(6) 2014 AND STILL HAS FBS OS WHEN LOOKING UPWARD. THE PT WILL RETURN TO THE CLINIC AFTER WORK INSTEAD OF TUESDAY, (B)(6) 2014. THE PT SAID SHE HAD NOT WORN CL'S SINCE (B)(6) 2014. THE PT SAID SHE IS APPLYING PRESCRIPTION EYEDROPS APPROXIMATELY EVERY HOUR AND WILL USE THEM UP SOON. ON (B)(6) 2014, THE PT WAS CONTACTED AND REPORTED THE FOLLOWING INFO: THE PT RETURNED TO THE ECP ON (B)(6) 2014 AND CORNEAL STAINING HAD RESOLVED. THE PT SAID SHE WAS ALLOWED TO RESUME CL WEAR. THE PT SAID SHE WAS DIAGNOSED WITH DRY EYE AND SAID THAT WAS THE FIRST TIME SHE RECEIVED THAT DIAGNOSIS. THE PT WAS PRESCRIBED DIQUAS FOR DRY EYE AND RIZABEN FOR THE PERSISTANT SWELLING IN THE UPPER EYELID. THE ECP WAS CONTACTED ON (B)(6) 2014 AND PROVIDED THE FOLLOWING INFO: THE PT WAS INITIALLY SEEN ON (B)(6) 2014 BY A DIFFERENT ECP. ON (B)(6) 2014, THE PT WAS SEEN AT THE ECP'S CLINIC COMPLAINING OF PAIN WITH CL WHICH HAD DEVELOPED ON (B)(6) 2014. THE PT HAD DEEP EPITHELIAL STAINING. THE STAINING WAS LOCATED AT THE CENTRAL CORNEA OS. "THE STAINING MIGHT HAVE BEEN GETTING INFECTED." THE PT WAS PRESCRIBED CRAVIT EYE DROPS. THE PT'S VA OS WAS NOT AFFECTED. ON (B)(6) 2014, THE PT RETURNED TO THE CLINIC AND WAS ALLOWED TO RESUME CL WEAR AT THAT TIME AND WAS PRESCRIBED RIZABEN EYE DROPS FOR ALLERGY OU. THE PT HAD A PRE-EXISTING ALLERGY. THE ECP SAID THE PT HAD CONSULTED THE ECP ONLY WHEN THERE IS SOMETHING WRONG WITH THE PT'S EYE SINCE 2012, AND HAD BEEN DIAGNOSED WITH ALLERGY. "THE ECP DETERMINED THAT THE ALLERGY WAS NOT CL-RELATED. THE ECP DETERMINED THAT IT WAS UNK WHETHER THE STAINING WAS CL-RELATED. WHEN THE ECP EXAMINED THE PT'S OS, THERE WAS CORNEAL STAINING REMAINING. THE ECP DOES NOT KNOW HOW THE STAINING DEVELOPED OR HOW THE OS CONDITION WAS AT THE TIME OF THE INCIDENT, THE ECP DETERMINED THAT THE STAINING WAS NOT SERIOUS." ON (B)(6) 2014, THE PT WAS CONTACTED; THE PT STILL HAD FBS OS WHEN LOOKING UPWARD. THE PT PLANNED TO PURCHASE CL'S ON SATURDAY (B)(6) 2014. THE PT CALLED ON (B)(6) 2014. THE PT HAD CONSULTED AN ECP TO PURCHASE CL'S AND THE PT HAD AN EYE EXAMINATION. THE PT "STILL HAD BUMPS AND INFLAMMATION ON THE EYELID." THE PT WAS ALLOWED TO WEAR CL'S AND WAS PRESCRIBED FLUOMETHOLONE EYE DROPS TO USE WHEN CL ARE NOT WORN. THE PT WAS PRESCRIBED ANOTHER BRAND OF CONTACT LENSES AND HAD A SLIGHT FOREIGN BODY SENSATION WHILE WEARING TRIAL LENSES. THE PT WAS CALLED ON (B)(6) 2014 AND SAID SHE SAW HER ECP ON (B)(6) 2014 DUE TO PERSISTENT FBS WITH THE COMPETITOR'S CONTACT LENSES AND WAS PRESCRIBED 42 SINGLE-USE VIALS OF MUCOSTA EYE DROPS TO USE FOR 10 DAYS AFTER THE TREATMENT OF "DRY EYE AND STAINING ON THE EYE LID." THE PT SAID SHE WAS NOT INSTRUCTED TO RETURN FOR FOLLOW-UP. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE PT RETURNED 2 LENSES IN LENS CASES. THE PARAMETERS OF THE LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. BOTH LENSES MET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. ONE LENS HAD AN EDGE TEAR, NO VISUAL ATTRIBUTES WERE OBSERVED ON THE OTHER LENS. AS THE LENSES WERE NOT RECEIVED IN SEALED BLISTER PACKAGES, THERE WAS NO SOLUTION AVAILABLE FOR ANALYSIS. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER NAD SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT B00GSJ5 WAS PRODUCED UNDER NORMAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258951 ACUVUE OASYS FOR ASTIGMATISM CONTACT LENSES SOFT CONTACT LENS LPL VISTAKON NA B00GSJ5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention