Medical Device Advisories

FDA Advisory No. 2019-006 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device Product (Freshlook Colorblends (phemfilcon A) Contact Lenses)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the counterfeit medical device product Freshlook Colorblends (phemfilcon A) Contact Lenses.

FDA, in coordination with the Market Authorization Holder (MAH), Alcon Laboratories (Phils.), Inc., has verified that the aforementioned medical device product is a COUNTERFEIT.

According to Alcon Laboratories (Phils.), Inc., the CIBA Vision Corporation – Illinois, USA already ceased production of Freshlook family soft contact lenses, which includes Freshlook (phemfilcon A) Colorblends Contact Lenses (DVR-4802) in November 2013 and last lots produced bear an expiration dating October 2018.

Accordingly, since this counterfeit medical device has not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The consumption of such violative product may pose potential health hazards to the consuming public.

In light of the above, the public is advised not to purchase and use the aforementioned violative product and to be vigilant against medical device that might not be duly registered with FDA. Always check if a medical device has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.

All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device product, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at This email address is being protected from spambots. You need JavaScript enabled to view it.. To report continuous sale or distribution of the above counterfeit medical device, utilize our online reporting facility, eReport, at www.fda.gov.ph/ereport, or e-mail us via This email address is being protected from spambots. You need JavaScript enabled to view it., or call us at the Center for Device Regulation, Radiation Health and Research (CDRRHR) hotline (02) 857-1900 local 8301.

 

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