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

Recall date

November 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0865-2019

FDA classification

Class I

Brand / firm

RVO 2.0, INC

Sold / distributed

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.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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