Z-0865-2019 Class I Terminated
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