Recall Z-0865-2019— RVO 2.0, INC
Class I · Terminated
Class I FDA medical device recall by RVO 2.0, INC, initiated 2018-11-13, terminated 2024-03-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.. Reason: During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device..
- Recalling firm
- RVO 2.0, INC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-11-13
- Terminated
- 2024-03-14
- Firm location
- Aliso Viejo, CA, United States
Product description
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Reason for recall
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.