BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS BRAND CONTACT LENSES WITH HYDRACLEAR

    MDR report key: 1003541 · Received February 26, 2008

    Report

    Report Number
    1033553-2008-00026
    Event Type
    Injury
    Date Received
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    P040045
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT SENT EMAIL 01/29/2008 TO REPORT THE FOLLOWING INFORMATION: THE PATIENT REPORTED THAT THREE MONTHS PRIOR, HE DEVELOPED CORNEAL ULCERS IN BOTH EYES WHILE WEARING OASYS BRAND CONTACT LENSES. THE PATIENT REPORTED DISCONTINUING CONTACT LENS WEAR FOR TWO WEEKS AND BEING TREATED WITH "DROPS." THE PATIENT REPORTED UPON RESUMING CONTACT LENS WEAR ULCERS RETURNED IN BOTH EYES AFTER ONE WEEK. THE PATIENT REPORTED USING "OPTI-FREE" CLEANING SOLUTION. THE PATIENT REPORTED THAT TREATING DOCTOR STATED THAT THE BRAND OF SOLUTION THAT THE PATIENT WAS USING "IS WHAT CAUSED MY PROBLEMS." MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT HAS NOT RESPONDED. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME. LOT NUMBER OF THE PRODUCT IN QUESTION IS UNKNOWN. AS A CORNEAL ULCER MAY OR MAY NOT BE A SERIOUS INJURY, THIS EVENT IS BEING REPORTED AS WORSE CASE. ALCON WAS CONTACTED TO INFORM THEM OF THE PATIENT'S COMMENTS AND PATIENT CONTACT DETAILS WERE PROVIDED. WILL PROVIDE ANY ADDITIONAL INFORMATION WITHIN 30 DAYS UPON RECEIPT. ALL MDR REPORTS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention