RVO 2.0, INC recalls Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

Recalled March 13, 2019 · FDA recall Z-0865-2019 · RVO 2.0

Hazard

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

Units

2869

Sold at

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.

Description

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

Product

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

Manufacturer(s)

RVO 2.0, INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →