Z-0865-2019Class I

Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc

Name: Z-0865-2019 Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc
Creator: Rvo 2.0, Inc
Published: 2018-11-13
License: https://open.fda.gov/license/

Rvo 2.0, Inc / initiated 2018-11-13 / Terminated

FDA source

RVO 2.0, INC began a recall of Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc on 2018-11-13. FDA classified it as Class I and gives the reason as "During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0865-2019
Classification: Class I
Status: Terminated
Initiated: 2018-11-13
Posted: 2019-03-05
Terminated: 2024-03-14
Recalling firm: Rvo 2.0, Inc
Product: Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Product code: LQE Implant, Corneal, Refractive
Reason for recall: During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
FDA root cause: Unknown/Undetermined by firm
Action: On 11/13/2018, the firm started emailing Urgent Medical Device Recall notices and acknowledgment forms to consignees. This recall notice was intended for 1) patients implanted with the Raindrop Inlay and 2) eye care providers. Eye care providers were asked to cease further implantation and to return unused affected devices to the recalling firm. Eye care providers were informed that patients implanted with affected devices should continue to see their eye care providers on a regular basis, preferably every 6-months and no less often than every 12 months. Also, patients who have had their devices explanted should maintain a follow-up schedule with their provider. The firm commits to physicians to support the patient's best interests and to continue the FDA post approval study to monitor the device's ongoing performance and safety. The firm requests that all consignees complete and return, acknowledgement forms, regardless of whether they do or do not have unused affected product to return. Acknowledgement forms should be returned via email to [email protected]. Customers with questions are encouraged to call 949-330-6511.
Quantity in commerce: 2869
Distribution: U.S.: NV, GA, NY, MN, TX, ND, AZ, VA, SD, IN, MA, MO, CA, NC, UT, IL, NH, OH, OK, FL, NJ, TN, MI, PA, HI, ID, KY, NE, AL, LA, CO, MD, MS, OR, WI, AR, WA; No OUS (Foreign) Distribution.
Product codes and lots: All lots of unused product

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0865-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0865-2019	Class I	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-05

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)