BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS WITH HYDRACLEAR PLUS

    MDR report key: 1436243 · Received June 23, 2009

    Report

    Report Number
    1033553-2009-00044
    Event Type
    Injury
    Date Received
    June 23, 2009
    Date of Event
    January 1, 2008
    Report Date
    June 22, 2009
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LABELED FOR SINGLE USE AND REUSE. DEVICE DISCARDED, UNABLE TO FOLLOW UP.

    Description of Event or Problem · 1

    WE RECEIVED INFO THROUGH A MEDWATCH REPORT INDICATING AN OPTOMETRIST (OD) HAD 47 CASES OF EKC IN 2008. THE OD REPORTED THAT MANY OF THE CASES INVOLVED ACUVUE OASYS OR ADVANCE LENSES AND OPTI-FREE REPLENISH SOLUTION. THE OD WAS CONTACTED AND SAID 47 PT'S IN HIS PRACTICE HAD DEVELOPED CORNEAL INFILTRATES. THIRTY PT'S WORE ACUVUE OASYS LENSES AND 3 PT'S WORE ACUVUE ADVANCE LENSES. MOST OF THE INFILTRATES WERE OU AND CENTRAL. HE SAID THEY WERE WELL DEFINED AND HAD A "SNOWFLAKE" LIKE APPEARANCE AND THEY WERE ALL STERILE INFLAMMATORY REACTIONS. THE INFILTRATES ALL RESOLVED AND ALL OF THE PTS RESUMED CONTACT LENS WEAR WITH HYDROGEL LENSES. FOUR PTS HAD CELLS IN THE ANTERIOR CHAMBER. THIS REPORT IS TO DOCUMENT THE IRITIS IN THE ANTERIOR CHAMBER OF THE PT IDENTIFIED AS PT 12. THE PT WORE ACUVUE OASYS LENSES AND USED OPTI-FREE REPLENISH SOLUTION. THE PT'S VA OD WAS 20/20 AND OS 20/25 . THE PT HAD 4 INFILTRATES OD AND 3 INFILTRATES OS AND INJECTION OD WAS GRADE 2 AND OS GRADE 1. THE PT HAD 1+ CELLS IN THE OD ANTERIOR CHAMBER. THERE WERE NO CELLS IN THE OS ANTERIOR CHAMBER. TREATMENT: ALREX AND BLINK. THE OD REPORTED THAT THE SIGNS AND SYMPTOMS RESOLVED AND THE PT RETURNED TO WEARING HYDROGEL CONTACT LENSES. THE ECP DID NOT SAVE THE LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS WITH HYDRACLEAR PLUS SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other