BEUDAMED
    FDA Enforcement Class II Terminated

    Prescription eyeglass safety lenses. Vision correction

    Recall: Z-0167-2015 · Reported November 12, 2014

    Enforcement

    Recall Number
    Z-0167-2015
    Event ID
    69345
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Eyemart Express Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2014
    Initiation Date
    September 12, 2014
    Classification Date
    November 3, 2014
    Termination Date
    October 9, 2015
    Address
    13800 Senlac Dr Ste 200, N/A, Farmers Branch, TX, 75234-8823, United States

    Description

    Prescription eyeglass safety lenses. Vision correction

    Reason

    Prescription eyeglass safety lenses did not meet specifications.

    Code Info

    No lot codes are applied. The recalled products contain the following model numbers: LC Elite 1.50 80mm HC, LC Elite 1.50 80mm Suntech GRY, LC Elite Poly 75mm Suntech GRY, LC Elite Poly 77mm HC, LC SFSV 1.67 Suntech3 GRY, LC SFSV 75mm Trivex STG, LC Short Elite Poly 77mm HC, LC Short Elite Poly Suntech GRY, Poly FT-28 with scratch coat, Poly LifeRX Photo FT 7x28 Brown, Poly LifeRx Photo FT-28 Gray, Poly SFSV LifeRx Photo Gray, Poly SFSV with scratch coat, SF SUMMIT ECP 167 TRN7 GY 70mm, SF SUMMIT ECP 167 TRN7 GY 75mm, SF SV 1.53 T7 GY 75mm, SF SV 70mm PHOENIX COT, SFSV 167 Clear, Transitions VI Gray D28

    Distribution

    Nationwide Distribution including AK, AL, AR, CA, LA, MD, MO, MS, MT, NC, ND, NM, OH, OK, TN, SC, TX, VA, WI, and WV.

    Quantity

    76 pairs of eyeglasses