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Raindrop Near Vision Inlay

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

PMA P150034

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

2 closed

Documents

PMA P150034↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP150034 Date29 Jun 2016ApprovedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0865-2019 FDA Class I initiated 13 Nov 2018

    During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.

    • Terminated Z-1518-2017 FDA Class II initiated 7 Feb 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 topical medications or lubricants should not be administered until centration of the inlay and proper flap positioning has been confirmed at the slit lamp.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
ReVision Optics Raindrop Near Vision Inlay
Trade Name
Raindrop Near Vision Inlay
Generic Name
Implant, corneal, refractive
PMA Number
FDA Product Code
LQE
Device Class
Class III
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Raindrop Near Vision Inlay is a corneal refractive implant designed for intrastromal implantation. It is indicated to improve near vision in the non-dominant eye of phakic, presbyopic patients aged 41 to 65 years with specific refractive criteria.

This device is supplied as a sterile, single-use implant. It is intended for use in ophthalmic surgical settings and has received FDA PMA approval under product code LQE. Storage and handling must follow manufacturer guidelines to maintain sterility and integrity prior to implantation.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Raindrop Near Vision Inlay used for?

    The Raindrop Near Vision Inlay is indicated for intrastromal implantation to improve near vision in the non-dominant eye of phakic, presbyopic patients aged 41 to 65 years who have a manifest refractive spherical equivalent between +1.00 D and -0.50 D with up to 0.75 D of refractive cylinder and require near correction of +1.50 D to +2.50 D of reading add.

  • Is the Raindrop Near Vision Inlay reusable or single-use?

    The Raindrop Near Vision Inlay is supplied as a sterile, single-use implant and must not be reused, resterilized, or implanted in more than one patient.

  • What regulatory authorization does the Raindrop Near Vision Inlay have?

    The Raindrop Near Vision Inlay has received FDA Premarket Approval (PMA) under application number P150034, as indicated in the device data.