|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER|
|Classification Name||lenses, soft contact, extended wear|
|Generic Name||contact lenses|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes for the device. The changes will add additional statements to the "precautions" section of the package insert to alert both doctors and patients about visual symptoms and/or peripheral awareness that patients might experience due to a reduction in the visible light transmission. The following additional precaution statement will be added to the package insert: "due to reduction in light transmittance with cosmetically tinted lenses, some patients may experience visual symptoms while wearing acuvue 2 colours brand. In addition, some patients may experience peripheral awareness due to the opaque iris pattern. " the following additional precaution statement will be added to the patient instruction guides: "when wearing lenses that alter your eye color, you may notice temporary differences in your vision due to a change in the amount of light that enters your eyes. If these differences in vision persist when wearing acuvue 2 colours brand, it is important that you consult your eye care professional. ".