RVO 2.0, INC: Medical Device Recall in 2019 - (Recall #: Z-0865-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: November 13, 2018

Date Posted: March 13, 2019

Recall Number: Z-0865-2019

Event ID: 81812

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.

Status: Terminated

Product Quantity: 2869

Code Information:

All lots of unused product

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated