Recall Z-1518-2017— Revision Optics Inc
Class II · Terminated
Class II FDA medical device recall by Revision Optics Inc, initiated 2017-02-07, terminated 2017-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Raindrop Near Vision Inlay, Model# RD1-1. 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..
- Recalling firm
- Revision Optics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-07
- Terminated
- 2017-06-21
- Firm location
- Lake Forest, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.