BEUDAMED
    FDA Recall Open, Classified

    ISee Ortho-K Lens

    Recall: Z-2515-2023 · Initiated June 26, 2023

    Recall

    Recall Number
    Z-2515-2023
    Event Number
    92719
    Firm
    PARAGON VISION SCIENCES, Inc
    FEI Number
    3013398957
    Product Code
    NUU
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 26, 2023
    Posted
    September 5, 2023
    Address
    2120 W Guadalupe Rd, Ste 112, Gilbert, AZ, 85233-2810

    Description

    ISee Ortho-K Lens

    Reason

    Manufactured lenses are not covered by existing FDA approval

    Action

    On June 26, 2023, CooperVision on behalf of Paragon Vision Sciences issued an email communication indicating they had suspended U.S. Distribution. On July 26, 2023, CooperVision issued a "Urgent Medical Device Correction" notice to affected consignees via: letter or E-Mail. CooperVision asked consignees to take the following actions: 1. Existing patients should be transitioned from the iSee/Fargo product to an alternate treatment as soon as possible. 2. Identify appropriate alternate options for the patients. Potential alternative options include the, CooperVision issued a "Urgent Medical Device Correction" notice to affected consignees. following: " Different lenses, including those available from other manufacturers that you determine to be appropriate based on your assessment of patient suitability and treatment type. " Glasses that can provide the appropriate reduction in myopic refractive error for the patient, based on your assessment of patient suitability and treatment type. 3. During this transition time, current patients can continue to wear their lenses to continue their treatment. This includes continued access to replacement lenses as deemed necessary by you, the ECP, until the patient can be adequately refit and transitioned to a different product to continue their treatment. NOTE: This only applies to patients currently undergoing treatment with these lenses. No new patients will be provided access to these lenses. 4. Sign and return a copy of the attached Medical Device Correction Response Form acknowledging your receipt and understanding of the provided information. 5. Provide a copy of this letter to your patients. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Canada, China, Japan, Vietnam.

    Quantity

    83,542 lenses