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 raindrop® near vision inlay. This device is indicated for intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients, 41 to 65 years of age, who have manifest refractive spherical equivalent of (mrse) +1. 00 diopters (d) to -0. 50 d with less than or equal to 0. 75 d of refractive cylinder, who do not require correction for clear distance vision, but who do require near correction of +1. 50 d to +2. 50 d of reading add.
| Device | Raindrop Near Vision Inlay |
| Classification Name | Implant, Corneal, Refractive |
| Generic Name | Implant, Corneal, Refractive |
| Applicant | RVO 2.0, Inc. (d.b.a. Optics Medical) |
| Date Received | 2015-09-24 |
| Decision Date | 2016-06-29 |
| Notice Date | 2016-07-08 |
| PMA | P150034 |
| Supplement | S |
| Product Code | LQE |
| Docket Number | 16M-1837 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RVO 2.0, Inc. (d.b.a. Optics Medical) 65 Enterprise Suite 455 aliso Viejo, CA 92656 |
| 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 |
|---|---|---|
| P150034 | Original Filing | |
| S009 | 2021-12-09 | Normal 180 Day Track No User Fee |
| S008 | 2019-08-19 | Normal 180 Day Track No User Fee |
| S007 | 2017-12-21 | Normal 180 Day Track No User Fee |
| S006 | 2017-12-18 | 30-day Notice |
| S005 | 2017-09-29 | Normal 180 Day Track |
| S004 | 2017-09-29 | 30-day Notice |
| S003 | 2017-02-03 | Special (immediate Track) |
| S002 | 2016-07-29 | Normal 180 Day Track No User Fee |
| S001 | 2016-07-29 | Normal 180 Day Track No User Fee |