Revision Optics Inc recalls Raindrop Near Vision Inlay, Model# RD1-1

Recall date

February 7, 2017

Source

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

Recall number

Z-1518-2017

FDA classification

Class II

Brand / firm

Revision Optics Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Raindrop Near Vision Inlay, Model# RD1-1