PMA · Approved
Recalled · Class I · 2018Raindrop Near Vision Inlay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rvo 2.0, Inc. (D.B.A. Optics Medical) · LQE Implant, Corneal, Refractive
Approved on Jun 29, 2016 through premarket approval, which rests on the device’s own clinical evidence after a 279-day review. It has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Jun 29, 2016
- Review
- 279 days
- Class
- Class III
- Product code
- LQE
- Recalls
- 2 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P150034 has 9 supplements since 2016: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 1 |
| 2022 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2018 | Class I | Z-0865-2019 | Unknown/Undetermined by firm | During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device. |
| Feb 7, 2017 | Class II | Z-1518-2017 | Use error | ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap and that topical medications or lubricants should not… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LQE devicesLQE Implant, Corneal, Refractive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LQE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LQE
Too few LQE 510(k)s in any year since 2007 to give a median.
Recalls per year · LQE
1in 2018
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LQE
1in 2025
MAUDE reports naming product code LQE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 4 | — | 0 | 37 |
| 2017 | 4 | — | 0 | 183 |
| 2018 | 4 | — | 1 (1) | 34 |
| 2019 | 1 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P150034 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150034: Raindrop Near Vision Inlay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150034
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026