PMA P870024S043

Device

PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..

Applicant

CooperVision, Inc.

PMA number

P870024

Supplement

S043

Product code

NUU

Decision date

2002-06-13

Classification

Lens, Contact, Orthokeratology, Overnight

Generic name

Lens, contact, orthokeratology, overnight

Approval order statement

APPROVAL FOR THE FOLLOWING DEVICES AND INDICATIONS: THE PARAGON CRT (PAFLUFOCON B) AND PARAGON CRT 100 (PAGLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES FOR CORNEAL REFRACTIVE THERAPY ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN A CONTACT LENSES 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. THE PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES FOR CORNEAL REFRACTIVE THERAPY ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN A CONTACT LENS CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 3.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.50 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.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P870024S043B.pdf" target="_new">Summary of Safety and Effectiveness</a>