BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREVISION 2 (BALAFILCON A) CONTACT LENS

    MDR report key: 2872132 · Received December 5, 2012

    Report

    Report Number
    1313525-2012-00039
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPL
    PMA / PMN Number
    K972454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LENS WAS EVALUATED AND FOUND TO BE WITHIN ALL SPECIFICATIONS, NO PRODUCT DEFECT WAS FOUND. MEDICAL DOCUMENTATION FROM THE TREATING DOCTOR WAS NOT PROVIDED. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    OPTICIAN IN PORTUGAL REPORTED A PT HAVING PAIN, RED EYE, BLURRED VISION, AND LIGHT SENSITIVITY IN LEFT EYE. ACCORDING TO THE PT, A VISIT WAS MADE TO AN EYE DOCTOR WHO DIAGNOSED INFLAMMATION AND PUS ON THE IRIS. PT WAS TREATED WITH DICLOFENAC VOLTAREN COLIRIO, MOXIFLOXACINO, PREDNISOLONA OFTALMICA, AND CARBOMER OFTALMICO. THE PT CLAIMS THE DOCTOR RELATES EVENT TO THE CONTACT LENS. THE TREATING DOCTOR CANNOT BE CONTACTED FOR FURTHER INFORMATION. PER THE OPTICIAN, THE PT IS STILL UNDER TREATMENT AND IT IS UNKNOWN IF THE OPTICIAN WILL OBTAIN FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREVISION 2 (BALAFILCON A) CONTACT LENS LPL BAUSCH & LOMB R28506861

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention