Z-0865-2019 Class I Terminated
FDA device recall Z-0865-2019 was initiated by RVO 2.0, INC on November 13, 2018 and is designated Class I. 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. The recall status is terminated (terminated March 14, 2024). Affected quantity: 2869.
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2019
- Initiation Date
- November 13, 2018
- Termination Date
- March 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2869
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.
Distribution Pattern
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.
Code Information
All lots of unused product