BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE UNSPECIFIED PRODUCT

    MDR report key: 2041989 · Received March 31, 2011

    Report

    Report Number
    1610287-2011-00031
    Event Type
    Injury
    Date Received
    March 31, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ALCON - FORT WORTH / ALCON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE WAS NOT REC'D FOR EVAL. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. ADD'L INFO WAS REQUESTED BY MAIL ON 03/01/2011, 03/22/2011 AND BY PHONE ON 03/09/2011, 03/22/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE EXPERIENCED AN EYE INFECTION FOLLOWING USE OF THIS PRODUCT. SHE STATED THAT THE PRODUCT MADE HER LENSES VERY BLURRY AND HER EYES ITCH. SHE REPORTED SHE HAD AN EYE EXAM AND WAS GIVEN A PRESCRIPTION FOR SPECIAL DROPS TO TREAT THE SWELLING. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE UNSPECIFIED PRODUCT LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ALCON LABORATORIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other