BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE UNSPECIFIED PRODUCT

    MDR report key: 1631424 · Received March 12, 2010

    Report

    Report Number
    1610287-2010-00015
    Event Type
    Injury
    Date Received
    March 12, 2010
    Report Date
    February 12, 2010
    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
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 02/12/2010 AND 02/24/2010 AND RECEIVED ON 02/24/2010. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE HAD INFLAMED CORNEAS FOLLOWING USE OF THIS PRODUCT. SHE STATED THAT SHE HAD RECENTLY HAD TROUBLE WITH HER VISION AND SAW HER EYE DOCTOR WHO ADVISED HER TO DISCONTINUE THE PRODUCT. THE CONSUMER INDICATED THAT THE DOCTOR SAID SHE BECAME ALLERGIC TO THE PRODUCT WHICH RESULTED IN THE INFLAMMATION. THE INFLAMMATION RESOLVED WITH TREATMENT (NOT SPECIFIED) AND SHE HAS RETURNED TO WEARING HER CONTACT LENSES. ADDITIONAL INFORMATION 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACUVUE ADVANCE HYDRACLEAR CONTACT LENSES