| Note: 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. |
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| Device | Raindrop Near Vision Inlay |
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| Generic Name | Implant, corneal, refractive |
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| Applicant | RVO 2.0, Inc. (d.b.a. Optics Medical)
65 Enterprise Suite 455
Aliso Viejo, CA 92656 |
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| PMA Number | P150034 |
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| Date Received | 09/24/2015 |
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| Decision Date | 06/29/2016 |
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| Product Code |
LQE |
| Docket Number | 16M-1837 |
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| Notice Date | 07/08/2016 |
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| Advisory Committee |
Ophthalmic |
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| Clinical Trials | NCT01373580
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 |
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