Revision Optics Inc: Medical Device Recall in 2017 - (Recall #: Z-1518-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Raindrop Near Vision Inlay, Model# RD1-1

Product Classification:

Class II

Date Initiated: February 7, 2017

Date Posted: March 29, 2017

Recall Number: Z-1518-2017

Event ID: 76422

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.

Status: Terminated

Product Quantity: 1,279 devices

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

Voluntary or Mandated:

Voluntary: Firm initiated