Skip to content
Recall Observatory FDA recall evidence

Device product

Raindrop Near Vision Inlay, Model# RD1-1

Z-1518-2017

February 07, 2017

Class II

Product summary

Firm
Revision Optics Inc
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

    reason.no_named_rule · v1.0.0

    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.