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FDA issues warning against 7 unregistered contact lenses


By Analou de Vera

The Food and Drug Administration (FDA) has warned the public against the purchase and use of seven unregistered contact lenses.



The agency identified the unregistered products as Add Gray Contact Lens, GBT Contact Lens, G&G SI Soft Contact Lens, G&G SII Soft Contact Lens, CQ Plus Soft Contact Lens, K-Luv Soft Contact Lens, and Skinny Magic-eye Premium Contact Lens.

“The FDA verified through post-marketing surveillance that the above mentioned medical device is not registered and the Certificate of Product Registration (CPR) has not been issued,” it stated in its advisory no. 2019-176.

The agency said that it cannot guarantee the quality and safety of these products since they did not undergo the evaluation process of the FDA.

“In light of the foregoing, the public is hereby advised not to purchase this violative product in the market,” the FDA said.

“All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until the Certificate of Product Registration is issued, otherwise, regulatory actions and sanctions shall be strictly pursued,” it added.

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