FDA-Device2019-03-13Class I
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
RVO 2.0, INC
Hazard
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Sold states
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.
Affected count
2869
Manufactured in
26800 Aliso Viejo Pkwy, Ste 160, Aliso Viejo, CA, United States
Products
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2019Don't want to check this manually?
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