This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the euclid systems orthokeratology (oprifocon a) contact lenses for overnight wear. The lenses 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.
| Device | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR |
| Classification Name | Lens, Contact, Orthokeratology, Overnight |
| Generic Name | Lens, Contact, Orthokeratology, Overnight |
| Applicant | BAUSCH & LOMB |
| Date Received | 2001-10-26 |
| Decision Date | 2004-06-07 |
| Notice Date | 2004-06-14 |
| PMA | P010062 |
| Supplement | S |
| Product Code | NUU |
| Docket Number | 04M-0260 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAUSCH & LOMB 1400 North Goodman St. rochester, NY 14603-0450 |
| 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 |
|---|---|---|
| P010062 | Original Filing | |
| S011 | 2018-05-25 | Real-time Process |
| S010 | 2016-06-27 | 30-day Notice |
| S009 | 2011-05-31 | 30-day Notice |
| S008 | 2010-10-20 | Normal 180 Day Track No User Fee |
| S007 | 2009-10-13 | Normal 180 Day Track No User Fee |
| S006 | 2008-01-31 | Real-time Process |
| S005 | 2006-12-21 | Real-time Process |
| S004 | 2006-01-27 | 135 Review Track For 30-day Notice |
| S003 | 2005-04-18 | Normal 180 Day Track No User Fee |
| S002 | 2004-09-01 | Real-time Process |
| S001 | 2004-07-06 | Real-time Process |