Inspections, Compliance, Enforcement, and Criminal Investigations
Notification of Stolen Alcon/Ciba Vision Products
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Date Posted: 1/27/2012
Alcon is working with the U.S. Food and Drug Administration (FDA), industry cargo theft organizations, and law enforcement officials to recover CIBA VISION® brand contact lenses that were stolen on or about January 9, 2012 while being delivered to an Alcon distribution center in Georgia. The stolen products consist of FreshLook® ColorBlends® contact lenses, details for which are listed below and represent the only product from these lots that are in the marketplace. No product with the same lot number has been previously distributed.
ALCON®/ CIBA VISION® contact lenses are delivered in tamper-evident packaging to protect product integrity. These products are medical devices that require a prescription. Alcon and the FDA advise physicians, retailers, and consumers to purchase contact lenses only from trusted and reliable sources and to check all packaging for signs of tampering or damage prior to purchase and/or use. Do not use the product if the packaging appears to have been disturbed in any way. Be aware that an unusually low price may be an indication that the product may have been stolen. Stolen product may become contaminated, not function as intended, or may have been tampered with or handled improperly while outside of the legitimate supply chain.
All ALCON®/ CIBA VISION® products are safe and effective when used as directed and purchased from legitimate and reputable retail outlets and pharmacies.
Anyone who has information regarding this incident, or has received suspicious or unsolicited offers for the specified products, is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations (OCI) at 1-800-551-3989 or to visit the OCI Web Site (http://www.fda.gov/OCI).
Patient or customer inquiries should be directed to Alcon Customer Service at 800-862-5266 (available Monday through Friday from 8:00 am to 5:00 pm C.S.T.).
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.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
FreshLook® ColorBlends®, MED 145 -01.00 GRAY
6 Lenses per Pack
65 Packs totaling 390 Lenses
FreshLook® ColorBlends®, MED 145 -02.50 GRAY
6 Lenses per Pack
240 Packs totaling 1,440 Lenses
FreshLook® ColorBlends®UV, 860 145 -00.00 GRAY
2 Lenses per Pack
480 Packs totaling 960 Lenses
Alcon has taken quick and appropriate actions to ensure the safety of their products and will continue to work closely with law enforcement, the FDA, and distribution partners to maintain the integrity of the supply chain.