Paragon Z CRT (Tisilfocon a) Rigid Gas Permeable Contact Lenses for Contact Lens Corneal Refractive Therapy

FDA premarket approval P050031 · Lens, contact, orthokeratology, overnight

PMA numberP050031

Approval

Applicant
CooperVision, Inc.
Received
August 26, 2005
Decision date
November 16, 2006 (APPR)
Supplements
7, latest May 10, 2022
Product code
NUU – Lens, Contact, Orthokeratology, Overnight

Official FDA PMA record

Approval order statement

APPROVAL FOR THE PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY. THE LENSES ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 6.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.75 DIOPTERS. THE LENSES MAY BE DISINFECTED USING ONLY A CHEMICAL DISINFECTION SYSTEM. NOTE: TO MAINTAIN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE. FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.