|Trade Name||ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)|
|Classification Name||lenses, soft contact, extended wear|
|Applicant||VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes in the package insert and fitting and patient management guide pertaining to the acuvue(r) bifocal (etafilcon a) contact lens. The changes are designed to enhance practitioners' fitting performance and early visual success of the patient. No changes are made tot he remaining portions of approved labeling.