Device product
Raindrop Near Vision Inlay, Model# RD1-1
Z-1518-2017
Product summary
- Event
- Event 76422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,279 devices
- Official record key
device-enforcement:Z-1518-2017
Official wording
Reason: 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.
Code information: multiple lots since 08/01/2016
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
Derived failure modes
-
Unknown
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.