CIBA VISION FRESHLOOK ILLUMINATE PROFESSIONAL

There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint. Retained product from the same lot was evaluated and all testing was found to be within specification. Opened product from the same lot was returned and found to be out of specification due to being torn. Each lens is printed with a unique starburst pattern, which perfectly blends the coloured ring of the eye into the iris. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. FreshLook Illuminate contact lenses, by Alcon (formerly Ciba Vision,) are daily disposable contact lenses that are designed to enhance the natural beauty of your eyes, providing a natural look for everyday use. However, this medwatch is being filed based on a similar product freshlook on-day that is sold in the united states under pma/s1o (k) # k050213. Pma/510(k): this product is not approved or introduced into commercial distribution in the united states. No initial reporter info was provided due to privacy. It is noted that there is no further info, and the doctor will be in contact if the pt visits again.Īdditional info was received from the ecp on (b)(6) 2013, stating that the infiltration is getting better and no more eye drops have been prescribed. There was a 'non-serious infiltration' at 6 o' clock (peripheral) on the cornea. The pt had a follow up with the ecp on (b)(6) 2013 and at that time, the symptoms had not yet resolved.Īs of (b)(6) 2013, the pt has not returned to the ecp for follow up and they bare not sure if the pt will be returning.Īdditional info was received on (b)(6) 2013, from the ecp stating that on (b)(6) 2013, the pt was prescribed fluorometholone (anti-inflammatory) and levofloxacin (antibiotic). The pt visited the ecp on (b)(6) 2013 and was diagnosed with bacterial keratitis in the right eye. On the following day, the pt experienced pain, eye mucus and was unable to tear the contact lens. Freshlook One Day lenses are daily disposable.

The pt removed the lens and noted that it was torn. Freshlook One Day incorporates Freshlook 3-in-1 ColorBlends technology on the Dailies platform.

CIBA VISION FRESHLOOK ILLUMINATE PROFESSIONAL

It was reported by the eye care professional (ecp) that on (b)(6) 2013, the pt felt discomfort right after inserting the lens, but continued wearing the lens for several hours. More information about FreshLook IlluminatereshLook Illuminate contact lenses, by Ciba Vision, are daily disposable contact lenses that are designed to enhance.

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