FDA-Device2017-03-29Class II
Raindrop Near Vision Inlay, Model# RD1-1
Revision Optics Inc
Hazard
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.
Sold states
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
Affected count
1,279 devices
Manufactured in
25651 Atlantic Ocean Dr Ste A1, Lake Forest, CA, United States
Products
Raindrop Near Vision Inlay, Model# RD1-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2017Don't want to check this manually?
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