Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0865-2019 — Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.

U.S. FDA — Device Enforcement · United States · 2018-11-13 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0865-2019
Date of alert
2018-11-13
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
RVO 2.0, INC
Product category
device
Product type
Devices
Reported risk: During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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