BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLENS DAILY DISPOSABLE CONTACT LENS

    MDR report key: 6115802 · Received November 19, 2016

    Report

    Report Number
    0001313525-2016-00628
    Event Type
    Injury
    Date Received
    November 19, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    MVN
    PMA / PMN Number
    K061157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER REPORTED PAIN, DISCOMFORT, AND REDNESS IN LEFT EYE. CONSUMER VISITED EYE CLINIC AND REPORTED THAT DOCTOR NOTED EDEMA ON SCLERA AND A LITTLE SCRATCH ON THE CORNEA OF THE LEFT EYE. THE COMPLAINT SAMPLE WAS RETURNED AND THE RESULTS OF THAT EVALUATION REVEALED A PIECE OF MATERIAL (POM) LOOSE IN THE LENS CONTAINER AS WELL AS A TEAR ON THE EDGE OF THE LENS ITSELF. ACCOMPANYING LENSES THAT WERE RETURNED WERE EVALUATED AND THE RESULTS OF THE TESTING PERFORMED WERE ALL WITHIN SPECIFICATION. ADDITIONALLY, A REVIEW OF THE LOT DEVICE HISTORY RECORDS (DHR) SHOW THAT THE LOT WAS MANUFACTURED AS PER LOCAL AND GLOBAL PRODUCT SPECIFICATIONS. A REVIEW OF THE PACKAGING OPERATION REVEALED NO REJECTS FOR POM OR TORN LENS. NO IRREGULARITIES EXIST WITHIN THE DHR REVIEW TO INDICATE AN ISSUE WITHIN THE LOT. ISOLATED INCIDENCE. BASED ON AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    CONSUMER REPORTED PAIN, DISCOMFORT, AND REDNESS IN LEFT EYE UPON INITIAL USE OF PRODUCT. CONSUMER VISITED EYE CLINIC AND REPORTED THAT THE DOCTOR NOTED EDEMA ON SCLERA AND A LITTLE SCRATCH ON THE CORNEA OF THE CONSUMER'S LEFT EYE. CONSUMER WAS PRESCRIBED GATIFLO OPHTHALMIC SOLUTION AND HYALEIN OPHTHALMIC SOLUTION AND INSTRUCTED TO DISCONTINUE LENS WEAR UNTIL EYE RECOVERED. CONSUMER REPORTED SHE HAS RECOVERED. MEDICAL DOCUMENTATION FROM THE DOCTOR WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766523 SOFLENS DAILY DISPOSABLE CONTACT LENS LENS, CONTACT, DISPOSABLE MVN BAUSCH & LOMB INCORPORATED W62019126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other