BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAIRA SPHERE (ENFILCON A)

    MDR report key: 2394003 · Received December 23, 2011

    Report

    Report Number
    2640128-2011-00077
    Event Type
    Injury
    Date Received
    December 23, 2011
    Report Date
    November 29, 2011
    Manufacturer
    COOPER VISION CARRIBBEAN CORP.
    Product Code
    LPL
    PMA / PMN Number
    K071736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS REDUCED VISUAL ACUITY FOR MORE THAN 7 DAYS. METHOD: NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFORMATION BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE PT REPORTED HAZY VISION. FOLLOW UP WITH THE ECP ON (B)(6) 2011 NOTES THAT THE PT'S VISUAL ACUITY HAD DECREASED FOR MORE THAN 7 DAYS, HOWEVER, HAS HAD IMPROVEMENT WITH NO PERMANENT IMPAIRMENT OR DAMAGE. THE PT WAS TREATED WITH PRED FORTE AND MURO 128. DOCTOR ALSO NOTES THAT THE PT WORE A DIFFERENT PAIR OF LENSES PRIOR TO BEING TREATED FOR 2-3 WEEKS AFTER THE ONSET OF THE SYMPTOMS REPORTED. THIS IS BEING FILED AS REDUCED VISUAL ACUITY FOR MORE THAN 7 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAIRA SPHERE (ENFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPER VISION CARRIBBEAN CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other