Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Raindrop Near Vision Inlay Recalled by Revision Optics Inc Due to ReVision Optics has updated the instructions for use...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Revision Optics Inc directly.
Affected Products
Raindrop Near Vision Inlay, Model# RD1-1
Quantity: 1,279 devices
Why Was This 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.
Where Was This Sold?
This product was distributed to 29 states: AL, AZ, CA, FL, GA, HI, IL, IN, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, PA, SD, TN, TX, UT, WA
About Revision Optics Inc
Revision Optics Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report