BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM

    MDR report key: 3602065 · Received January 31, 2014

    Report

    Report Number
    2026940-2014-00001
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    January 5, 2014
    Report Date
    May 2, 2014
    Manufacturer
    KC PHARMACEUTICALS, INC.
    Product Code
    LPN
    PMA / PMN Number
    K010559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT WAS CONTACTED VIA TELEPHONE ON 01/06/13 AND ADMITTED TO NOT USING PRODUCT AS INSTRUCTED. COMPLAINANT RETURNED SAMPLE TO STORE OF PURCHASE. RECEIVED BARREL LENS CASE SAMPLE ONLY WITHOUT THE SOLUTION FROM (B)(6). SAMPLE WAS FORWARDED TO MANUFACTURER FOR EVALUATION. AS THE SOLUTION SAMPLE COULD NOT BE RETRIEVED A COMPLETE EVALUATION COULD NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    COMPLAINANT WAS CONTACTED VIA TELEPHONE ON (B)(4) 2013 AND ADMITTED TO NOT USING PRODUCT AS INSTRUCTED. COMPLAINANT RETURNED SAMPLE TO STORE OF PURCHASE. ATTEMPTED TO RETRIEVE SAMPLE FROM CVS, BUT THEY RESPONDED THAT SAMPLE WAS DAMAGED OUT AT STORE LEVEL. NO SAMPLE OR PRODUCT INFORMATION WAS ACQUIRED TO FURTHER INVESTIGATE COMPLAINT. SAMPLE COULD NOT BE RETRIEVED.

    Description of Event or Problem · 1

    ONE PATIENT (B)(6) STATED THAT SHE EXPERIENCED A BURNING SENSATION IN THE EYES AFTER USING MEDICAL DEVISE, CVS HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM. THE PATIENT MEDICAL RECORD IS NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT. INITIAL REPORT WAS SENT ON 01/24/14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67939 CVS HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM LENS CARE SOLUTION LPN KC PHARMACEUTICALS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other