# P150034: Raindrop Near Vision Inlay

- Pathway: PMA
- Applicant: Rvo 2.0, Inc. (D.B.A. Optics Medical)
- Decided: Jun 29, 2016 after 279 days
- Product code: LQE (Implant, Corneal, Refractive)
- Device class: 3
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 13, 2018 · Class I · Z-0865-2019: 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: 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 topica

Source page: https://510kreport.com/device/P150034
Methodology: https://510kreport.com/methodology