Device Recall Raindrop Near Vision Inlay 의 리콜

Recall

76422

Class 2

Z-1518-2017

2017-02-07

2017-03-21

Terminated

United States

2017-06-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153166

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.

A Dear Doctor letter was sent to inform customers that ReVision Optics wanted to share a surgical update regarding the Raindrop Near Vision Inlay procedure. Customers are informed that no ophthalmic medications or lubricants should be used immediately prior to or during placement of the Raindrop Near Vision Inlay. Only Balanced Salt Solution (BSS) should be used to irrigate under the flap during the Raindrop procedure. Customers are informed that ophthalmic medications or lubricants should be administered only after verifying proper inlay centration and flap positioning as observed at the slit lamp. This ensures that no further inlay or flap manipulation is required. ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only 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. Customers with questions are instructed to contact Luis Vargas regarding the surgical procedure update.