Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Raindrop Near Vision Inlay Recalled by RVO 2.0, INC Due to During a post approval study the firm found...
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 RVO 2.0, INC directly.
Affected Products
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Quantity: 2869
Why Was This Recalled?
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Where Was This Sold?
This product was distributed to 37 states: AL, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI
About RVO 2.0, INC
RVO 2.0, 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