MAUDE Adverse Event Report: OPTICS MEDICAL / RVO 2.0, INC RAINDROP INLAY; IMPLANT, CORNEAL, REFRACTIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blurred Vision (2137)

Event Type  malfunction  

Event Description

I had a raindrop inlay procedure performed when initially available.In fact, the md that performed mine did his first procedure on me.(b)(6) i have tried to reach him by phone because i no longer live in the area and i get a notification that the phone number is no longer in use.I also reached to the company optics medical who made the inlay and have had no success in reaching: phone number (b)(4) has a "general" mailbox that i left a message and have received no return call and info@opticsmedical.Com which i attempted from both my personal and business email addresses and they were returned blocked or undeliverable.Concerns: (2) fold 1) i have some blurring that started a while ago.When i initially could not reach dr (b)(6), i thought maybe due to covid so i have waited but not that the phone is saying no longer in use i believe there is more to it.I need to find an md who is familiar with this procedure in my area that i live now and am hoping you can assist me.I currently live in (b)(6), note: i am aware of the recall based on s/s of blurring; however dr.(b)(6) office never reached out to me to inform me of this, i recently had to go renew my driver's license and it took me several attempts to pass the visit test because i could not read through their machine with my left eye.If i had persisted, they would of failed me and not renewed.I was not provided a card or anything from dr.(b)(6) that identifies the type of inlay i have and what it does to be able to present in such situations.Is there something that can be sent to me at: (b)(6) my cell number is (b)(6) (i live off the lake and the service comes in and out) monday thru friday 8-5 my work number is (b)(6) please advise on what i need to do.I cannot recall the exact dates the inlay was put in.I was the first patient my doctor used the technique on; the product was brand new.Fda safety report id# (b)(4).

• Brand Name: RAINDROP INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): OPTICS MEDICAL / RVO 2.0, INC
• MDR Report Key: 11506070
• MDR Text Key: 240785871
• Report Number: MW5100036
• Device Sequence Number: 1
• Product Code: LQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR