PMA P990018S002

Device

MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR

Applicant

Menicon Co, Ltd.

PMA number

P990018

Supplement

S002

Product code

MWL

Decision date

2002-07-12

Classification

Lens, Contact (rigid Gas Permeable), Extended Wear

Generic name

Lens, contact (rigid gas permeable), extended wear

Approval order statement

APPROVAL FOR THE MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS. THIS DEVICE IS INDICATED FOR: MENICON Z (TISILFOCON A) SPHERICAL, ASPHERIC, NON-PRISM BALLAST TORIC AND NON-PRISM BALLAST MULTIFOCAL LENSES ARE INDICATED FOR EXTENDED WEAR (FROM 1 TO 30 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OF THE LENSES, AS RECOMMENDED BY THE EYECARE PROFESSIONAL) FOR THE CORRECTION OF REFRACTIVE ERROR (MYOPIA, HYPEROPIA, PRESBYOPIA AND/OR ASTIGMATISM) IN NON-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS MAY BE PRESCRIBED IN SPHERICAL AND ASPHERIC POWERS RANGING FROM -25.00 D TO +25.00 D FOR DAILY WEAR AND -25.00 D TO +8.00 D FOR UP TO 30 DAYS EXTENDED WEAR. TORIC LENSES ARE DESIGNED TO CORRECT UP TO 5.00 D OF ASTIGMATISM AND MULTIFOCAL LENSES TO PROVIDE UP TO +3.00 D OF READING ADD POWER FOR UP TO 30 DAYS EXTENDED WEAR. THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY. (THE MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS WAS CLEARED FOR DAILY WEAR UNDER K962006, K970019 AND K972443).

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P990018S002B.pdf" target="_new">Summary of Safety and Effectiveness</a>