BEUDAMED
    FDA Recall Terminated

    Soft Contact Lens

    Recall: Z-0529-2015 · Initiated October 28, 2014

    Recall

    Recall Number
    Z-0529-2015
    Event Number
    69496
    Firm
    Cooper Vision Caribbean Corp.
    FEI Number
    3002911336
    Product Code
    LPM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 28, 2014
    Posted
    December 15, 2014
    Terminated
    October 2, 2015
    Address
    500 Road 584, Amuelas Industrial Park Juana Diaz, PR, 00795

    Description

    Soft Contact Lens

    Reason

    Portions of the lots may contain units with an incorrect lens axis condition.

    Action

    This recall is being initiated to the wholesale/distributor and Eye Care Practitioner level. Written communications will be forwarded to all first level consignees by overnight mailin..9. Receipt" tracking and follow up with consignees will be conducted according to the Effectiveness Check noted below. . - . The 0ff Axis condition is ~onsistent with a situation in which use of, or exposure to, the product is unlikely to cause adverse health consequences. A user may notice blurred vision due to the axis being out of specification but removal of the lens effectively reduces/eliminates any impairment. There is currently no indication that use of a lens with an Off Axis condition will create an injury requiring medical intervention. No permanent impairment is anticipated with or without medical intervention. Based on the analysis " described in the attached Health Hazard Evaluation, CooperVision will initiate a Class Ill recall. As noted by regulation, this classification is consistent with a situation in which use of, or exposure to, the product is unlikely .to cause adverse health consequences. Our evaluation of the Off Axis condition indicates it is unlikely to cause an adverse health reaction. Based on a Class Ill determination, the recall shall be conducted to the Wholesale level with a planned Effectiveness Check at Level B - 50% of Consignees to be contacted. Public Warning- in light of the low risk and proposed recall classification; a public warning is not warranted at this time. Distribution includes: " North America: Canada, USA " Latin America: Argentina, Brasil, Chile, Colombia, Ecuador, Guatemala, Uruguay, Venezuela, Mexico " Europe: Belgium, Denmark, Germany, France, Netherlands, Poland, Spain, Sweden, Switzerland " Australia Returned lenses will be quarantined from distribution and destroyed as required. Actions and Dates: " Notify FDA through 806 Form on 10/23/14 " Initiate External communications starting 10/28/2014 " C

    Distribution

    US Nationwide Distribution.

    Quantity

    1170