Aliso Viejo, CA, United States
RVO 2.0, INC recalls
1 recall recorded since 2018, most recently on 13 November 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 13 November 2018
- Terminated
- 14 March 2024
- Reason
- During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0865-2019
- Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.