MAUDE Adverse Event Report: NIDEK INCORPORATED NIDEK EC-5000; EXCIMER LASER SYSTEM

Model Number EC-5000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Loss of Vision (2139)

Event Date 10/23/2019

Event Type  Injury  

Event Description

Vision problems; main problem: bright colored objects/text on dark backgrounds now glow in anything less than bright settings.The darker it is and the farther away the subject the worse it gets.The worst case i frequently deal with is playing a video game or watching a movie in the dark and seeing stuff like white subtitle text glowing, user interface elements glowing, actors glowing, really anything light against a dark background.This is not limited to screens however; even looking across a room at someone with a white shirt or fair skin standing against a dark wall their outline will glow.On a pure black oled screen (black pixels emit no light) with pure white text if i look carefully there's a fuzziness/almost a starburst like effect to the glow and it's fairly uniform around the entire outline.Alphagan/brimonidine tartrate drops to shrink my pupils mostly fixes this problem (like 80% probably) when used until they wear off.With my job as a video game developer this is extremely frustrating for me because these sort of bright objects/text/ui elements on dark backgrounds.Scenarios are common.Even having windows open but not in direct sunlight is still not bright enough to completely fix this at a distance of just my computer monitor on my desk.Second problem: after lasik there is a subtle background "light pollution" i notice most easily over dark objects.Its appearance is like a very faint version of what happens when you stare at a light bulb for a moment and then look away, still seeing that residual glow.I notice it more in dimmer environments.Third problem: i can't see clearly at very close distances to my face like i could before, this part of my vision is now blurry.I have to move an object at least 18cm away from my eyes before it becomes clear.Before surgery i could hold an object a good bit closer and still focus clearly on it.I think this might also be a spherical aberration side effect so same cause as the main issue above.There are other issues i notice that i think are related to the ones above.In dimly-lit settings such as a party indoors i find it harder to focus on people at a medium distance away from me; my depth perception feels off and their outline seems to blend into the background more.Indoors when someone walks in front of a bright window or monitor the light coming from behind them "wraps" around their outline now, obscuring them a bit at least around the edges.Car headlights/street lamps/etc., at night have the commonly reported starbursting / haloing effects to a distracting/annoying extent but not so bad that i can't safely drive at night.Pupil size measured at 7mm in low light.Surgery optical zone was only 6mm, device not capable of a large enough optical zone to avoid complications.Fda safety report id# (b)(4).

• Brand Name: NIDEK EC-5000
• Type of Device: EXCIMER LASER SYSTEM
• Manufacturer (Section D): NIDEK INCORPORATED
• MDR Report Key: 10028440
• MDR Text Key: 190170303
• Report Number: MW5094387
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC-5000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 86