BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA TORIC (ENFILCON A) CONTACT LENS

    MDR report key: 2380846 · Received August 12, 2011

    Report

    Report Number
    2640128-2011-00007
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    COOPER VISION CARIBBEAN CORP.
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS A REOCCURRING CORNEAL ULCER TREATED WITH MEDICATION. NO DIRECT CAUSAL RELATIONSHIP HAS BEEN ESTABLISHED BETWEEN THE MEDIAL DEVICE AND THE INCIDENT. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THE CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADDITIONAL INFO.

    Description of Event or Problem · 1

    PT EXPERIENCED HAZY/FOGGY VISION WITH LENSES SHORTLY AFTER INSERTION. THE PT WORE THE LENSES FOR A DAY AND A HALF. PT WENT TO ER ON (B)(6) 2011 DUE TO EYE PAIN. PT WAS DIAGNOSED WITH A CORNEAL ULCER IN THE RIGHT EYE. CONTACT LENS USE WAS TEMPORARILY DISCONTINUED FROM (B)(6) 2011. PT'S OCULAR STATUS RETURNED BACK TO NORMAL. ON (B)(6) 2011, PT NOTICED WHILE HAZY CLOUD COMING OVER VISION. DID NOT REMOVE CONTACT LENS THAT DAY. AFTER SECOND DAY OF WEARING, PT'S FELT GREAT PAIN UPON REMOVAL. VISION HAD BEEN WHITE AND HAZY ALL DAY IN THE RIGHT EYE. PT WAS UNABLE TO SLEEP THAT NIGHT DUE TO PAIN AND WENT TO SEE HER EYE DOCTOR FIRST THINK IN THE MORNING. ON (B)(6) 2011, PT WAS DIAGNOSED WITH A CORNEAL ULCER OF 8 MM ACROSS CENTRAL CORNEA IN THE RIGHT EYE. CONTACT LENS USE WAS TEMPORARILY DISCONTINUED FROM (B)(6) 2011 UNTIL COMPLETION OF TREATMENT. THE PRACTITIONER CHANGED THE CONTACT LENS BRAND AND DISCONTINUED LENS WEAR FOR THREE MONTHS FOR THE PT. UPON FOLLOW-UP ON (B)(6) 2011, CORNEAL ULCER HAD HEALED, BUT VISUAL ACTUALLY REMAINED REDUCED. EYECARE PRACTITIONER STATED IT IS UNK AT THIS POINT WHETHER VISUAL ACUITY WILL RETURN TO NORMAL 20/20. ON (B)(6) 2011, PRACTITIONER STATED PT VISUAL ACUITY WAS 20/25. HE EXPECTS IT SHOULD BE BACK TO 20/20 AT NEXT FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA TORIC (ENFILCON A) CONTACT LENS SOFT CONTACT LENS, DAILY WEAR, PRODUCT CODE: LPL LPL COOPER VISION CARIBBEAN CORP. 10489500003014

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other POLYSPORINE OINTMENT| IBUPROFEN| CIPROFLOXACINE| HOMATROPINE| VIGAMOX| VOLTARIN