FDA Adverse Event Malfunction Summary report: N

RAINDROP INLAY

MDR report key: 11506070 · Received March 16, 2021

Report

Report Number
MW5100036
Event Type
Malfunction
Date Received
March 16, 2021
Report Date
March 12, 2021
Manufacturer
OPTICS MEDICAL / RVO 2.0, INC
Product Code
LQE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

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 [email protected] 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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
396481 RAINDROP INLAY IMPLANT, CORNEAL, REFRACTIVE LQE OPTICS MEDICAL / RVO 2.0, INC

Patients

Seq Age Sex Outcome Treatment
1 57 YR