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Revision Optics Inc recalls Raindrop Near Vision Inlay, Model# RD1-1
Recalled March 29, 2017 · FDA recall Z-1518-2017 · Revision Optics
Hazard
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. · FDA Class II
Units
1,279 devices
Sold at
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
Description
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.
Product
Raindrop Near Vision Inlay, Model# RD1-1
Manufacturer(s)
Revision Optics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →