RVO 2.0 Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision recall — FDA Z-0865-2019
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Overview of recall records associated with RVO 2.0, Inc., including dates, categories and classifications where available.
Classification mix: Class I: 1.
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
This page summarizes recall records in which the official source identifies RVO 2.0, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.