510(k) Report

FDA applicant

Rvo 2.0, Inc. (D.B.A. Optics Medical)

Aliso Viejo1 decision2016–20162 recalls

FDA records 1 decision for Rvo 2.0, Inc. (D.B.A. Optics Medical) (Aliso Viejo) in 2016: 1 original PMA approval. All are in product code LQE (Implant, Corneal, Refractive). 2 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Rvo 2.0, Inc. (D.B.A. Optics Medical)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2018

2017: 12018: 1, 1 Class I
2016high 1 (2017) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Rvo 2.0, Inc. (D.B.A. Optics Medical) by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rvo 2.0, Inc. (D.B.A. Optics Medical)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LQEImplant, Corneal, Refractive1decision

What has FDA decided for it lately?

  • P150034Raindrop Near Vision InlayRvo 2.0, Inc. (D.B.A. Optics Medical) · 20161 Class I recall

The one decision as Rvo 2.0, Inc. (D.B.A. Optics Medical) →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P150034Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics…Nov 13, 2018Class I
  • P150034Raindrop Near Vision Inlay, Model# RD1-1Feb 7, 2017Class II