BEUDAMED
    FDA Recall Terminated

    SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. Ciba Vision Group, Duluth GA 30097 USA SoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons with non-diseased eyes that are myopic or hyperopic

    Recall: Z-1976-2011 · Initiated February 1, 2011

    Recall

    Recall Number
    Z-1976-2011
    Event Number
    57714
    Firm
    CIBA Vision Puerto Rico, Inc. El Jibaro
    FEI Number
    2648694
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 1, 2011
    Posted
    April 13, 2011
    Terminated
    November 30, 2011
    Address
    173 Km 1.1, Industrial Park Lots 1 & 2 Route, Cidra, PR, 00739

    Description

    SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. Ciba Vision Group, Duluth GA 30097 USA SoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons with non-diseased eyes that are myopic or hyperopic

    Reason

    Out of specification values were obtained for sterility testing. The pH of the saline solution may be higher than the spec (up to pH 8.6 compared to a spec limit of pH 7.8). The osmolarity of the saline solution may be lower than specification (263 mOsm/kg compared to a spec limit of 270)

    Action

    The firm, CIBA Vision, sent two letters of notification to its customers. First letter "IMPORTANT PRODUCT INFORMATION" dated June 2010 and the second "URGENT: Voluntary Product Recall" dated February 1, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: 1) complete the requested information on the attached SoftPerm (synergicon A) Lenses Reply Form and drop the form in the mail within 10 business days and 2) If they have any of the recalled SoftPerm (synergicon A) lenses (shipped to you after March 1, 2009) still in their possession, return as follows: Package the product and affix the prepaid UPS return label and ship within 10 business days or mail to CIBA VISION Corporation, c/o Stericycle Pharmaceutical Services, 2670 Executive Drive, Ste. A, Indianapolis, IN 46241, Atth: SoftPerm Recall. CIBA ask customers to please not include other products, lots, kits, packs, or competitor's products with their shipment. In addition, CIBA will issue a credit to the customers account upon receipt of the returned product. Please feel free to contact Stericycle at 877-542-5928 or CIBA VISION Technical Consultation Department at 1-800-241-7468 should you have any questions or concerns.

    Distribution

    Worldwide distribution: USA (nationwide) including PR; and countries including: Australia, Austria, Argentina, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Dubai (United Arab Emirates), Finland, France, Great Britain, Greece, Hungary, Iceland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Netherlands, Oman, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and Venezuela.

    Quantity

    28, 124