Z-1518-2017Class II

Raindrop Near Vision Inlay, Model# RD1-1

Name: Z-1518-2017 Raindrop Near Vision Inlay, Model# RD1-1
Creator: Revision Optics Inc
Published: 2017-02-07
License: https://open.fda.gov/license/

Revision Optics Inc / initiated 2017-02-07 / Terminated / root cause: labeling and UDI

FDA source

Revision Optics Inc began a recall of Raindrop Near Vision Inlay, Model# RD1-1 on 2017-02-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1518-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-07
Posted: 2017-03-21
Terminated: 2017-06-21
Recalling firm: Revision Optics Inc
Product: Raindrop Near Vision Inlay, Model# RD1-1
Product code: LQE Implant, Corneal, Refractive
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: A Dear Doctor letter was sent to inform customers that ReVision Optics wanted to share a surgical update regarding the Raindrop Near Vision Inlay procedure. Customers are informed that no ophthalmic medications or lubricants should be used immediately prior to or during placement of the Raindrop Near Vision Inlay. Only Balanced Salt Solution (BSS) should be used to irrigate under the flap during the Raindrop procedure. Customers are informed that ophthalmic medications or lubricants should be administered only after verifying proper inlay centration and flap positioning as observed at the slit lamp. This ensures that no further inlay or flap manipulation is required. ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only 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. Customers with questions are instructed to contact Luis Vargas regarding the surgical procedure update.
Quantity in commerce: 1,279 devices
Distribution: US: AL, AZ, CA, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WA
Product codes and lots: multiple lots since 08/01/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1518-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1518-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21

Product code LQE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)