Z-1518-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 7, 2017
- Termination Date
- June 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,279 devices
Product Description
Raindrop Near Vision Inlay, Model# RD1-1
Reason for Recall
ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap and that topical medications or lubricants should not be administered until centration of the inlay and proper flap positioning has been confirmed at the slit lamp.
Distribution Pattern
US: AL, AZ, CA, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WA
Code Information
multiple lots since 08/01/2016