BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM

    MDR report key: 3620828 · Received February 10, 2014

    Report

    Report Number
    2026940-2014-00003
    Event Type
    Injury
    Date Received
    February 10, 2014
    Date of Event
    January 7, 2014
    Report Date
    May 5, 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

    ASSAY RESULTS ARE PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4). AS WE DID NOT RETRIEVE COMPLAINT SAMPLE FOR BARREL LENSE CASE, THE RETURNED COMPLAINT SAMPLE SOLUTION WAS EVALUATED USING A RETAINED SAMPLE OF BARREL LENS CASE. BASED ON MANUFACTURER PH SPECIFICATIONS 6.18 - 6.60 AND 6.37- 6.85 PRE-NEUTRALIZATION AND POST-NEUTRALIZATION RESPECTIVELY. THE PRE-NEUTRALIZATION PH 6.14 AND POST-NEUTRALIZATION PH 6.31 WERE SLIGHTLY OUT OF SPECIFICATION. ALTHOUGH THE PH WERE NOTED TO BE SLIGHTLY OUT OF SPECIFICATIONS, MANUFACTURER STATES THE PH RESULTS ARE AT A LEVEL THAT IS RECOGNIZED AS AN ACCEPTABLE PH RANGE 6.0-8.0 FOR OPHTHALMIC SOLUTION PER US PHARMACOPEIA (USP36/NF31).

    Description of Event or Problem · 1

    ONE (1) PATIENT (B)(6) STATED THAT HE EXPERIENCED A BURNING SENSATION IN THE EYES AFTER USING MEDICAL DEVICE, (B)(6) HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT. INITIAL REPORT WAS SENT ON 02/10/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88564 CVS HYDROGEN PEROXIDE CLEANING & DISINFECTING LENS CARE SYSTEM LENS CARE SOLUTION LPN KC PHARMACEUTICALS, INC. 107097

    Patients

    Seq Age Sex Outcome Treatment
    1 Other