This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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).
| Device | MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR |
| Classification Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Generic Name | Lens, Contact (rigid Gas Permeable), Extended Wear |
| Applicant | MENICON CO. LTD. |
| Date Received | 2001-11-28 |
| Decision Date | 2002-07-12 |
| Notice Date | 2002-08-06 |
| PMA | P990018 |
| Supplement | S002 |
| Product Code | MWL |
| Docket Number | 02M-0335 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MENICON CO. LTD. 269 A Ballardvale Street wilmington, MA 01887 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990018 | Original Filing | |
| S008 | 2022-02-07 | Normal 180 Day Track |
| S007 | ||
| S006 | 2021-01-21 | Normal 180 Day Track No User Fee |
| S005 | 2018-11-28 | Normal 180 Day Track |
| S004 | 2009-04-01 | Normal 180 Day Track No User Fee |
| S003 | 2002-10-21 | Real-time Process |
| S002 | 2001-11-28 | Panel Track |
| S001 | 2000-07-28 | Normal 180 Day Track |