BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM

    MDR report key: 6365397 · Received February 28, 2017

    Report

    Report Number
    9615939-2017-00003
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    January 10, 2017
    Report Date
    March 23, 2017
    Manufacturer
    SAUFLON PHARMACEUTICALS, LTD.
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AS AN ADVERSE EVENT, NOT A PRODUCT PROBLEM (E.G. DEFECT/MALFUNCTION).

    Additional Manufacturer Narrative · 1

    PRODUCT SAMPLE WAS RETURNED FOR EVALUATION AND A VISUAL INSPECTION WAS COMPLETED, IT WAS FOUND THAT THE INCORRECT BARREL CASE WAS RETURNED WITH AN OPEN BOTTLE OF SOLUTION. THE BARREL CASE RETURNED BY THE CONSUMER FOR EVALUATION IS FOR USE WITH MULTIPURPOSE SOLUTION; IT DOES NOT CONTAIN THE PLATINUM NEUTRALIZING DISC FOR USE WITH HYDROGEN PEROXIDE LENS CLEANING SYSTEM. THE INCIDENT HAS RESOLVED AND THE PATIENT HAS RECOVERED WITHOUT PERMANENT IMPAIRMENT OF EYE FUNCTION OR DAMAGE TO BODY STRUCTURE. THIS INCIDENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE PRODUCT DEFECT IN COMBINATION WITH THE SEVERITY OF THE PATIENT'S REACTION AND EXTENT OF MEDICAL TREATMENT PROVIDED AND MEDICATIONS PRESCRIBED TO TREAT THE INJURY.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED PAIN AND IRRITATION IN THE RIGHT EYE (OD) UPON INSTILLING HER CONTACT LENS (BRAND OR PRODUCT TYPE UNKNOWN) AFTER USING ONE STEP PEROXIDE LENS CLEANING SYSTEM. THE PATIENT SOUGHT EMERGENCY MEDICAL TREATMENT WHERE SHE WAS DIAGNOSED WITH OCULAR SURFACE INFLAMMATION, CHEMOSIS, BULBAR CONJUNCTIVA CHEMICAL BURN AS WELL AS A SMALL CORNEAL CHEMICAL BURN. THE PATIENT WAS PRESCRIBED CYCLOPENTOLATE, DEXAMETHASONE, CHLORAMPHENICOL, HYABAK, AND VITA-POS. THE PATIENT WAS SEEN FOR FOLLOW UP BY HER PRIMARY EYE CARE PROVIDER WHO INDICATES THE PATIENT IS FULLY RECOVERED AND THE INCIDENT HAS RESOLVED AS OF (B)(6) 2017. THE PATIENT INDICATES THAT THE PRODUCT WAS DEFECTIVE IN THAT THE BARREL CASE SUPPLIED WITH THE SYSTEM DID NOT CONTAIN THE PLATINUM NEUTRALIZING DISC RESULTING IN UN-NEUTRALIZED HYDROGEN PEROXIDE CLEANING SOLUTION BEING INSTILLED DIRECTLY INTO THE EYE. THIS INCIDENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION DUE TO THE PRODUCT DEFECT IN COMBINATION WITH THE SEVERITY OF THE PATIENT'S REACTION AND EXTENT OF MEDICAL TREATMENT PROVIDED AND MEDICATIONS PRESCRIBED TO TREAT THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149067 ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM LPN SAUFLON PHARMACEUTICALS, LTD. 137020

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other