P040029b欧几里得角膜塑形镜.pdfVIP

SUMMARY OF SAFETY AND EFFECTIVENESS DATA GENERAL INFORMATION Device Generic Names: oprifocon A rigid gas permeable contact lenses Device Trade Names: JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear Applicants Name and Address: Szabocsik and Associates 203 North Wabash Avenue Suite 1200 Chicago, IL 60601 Premarket Approval Application (PMA) Number: P040029 Panel Recommendation: None Date of Notice of Approval to Applicant: HI. INDICATIONS FOR USE JSZ Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear for the temporary reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system. Note: To maintain the Orthokeratology 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. III. Center for Devices and Radiological Health (CDRH) Decision This application includes by reference the data in PMA P010062 for the Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear by Euclid Systems Corporation