MAUDE Adverse Event Report: MED-LOGICS, INC. ML7 MICROKERATOME; KERATOME, AC-POWERED

Model Number ML7

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Therapeutic Response, Decreased (2271)

Event Date 10/23/2019

Event Type  Injury  

Event Description

I underwent lasik in (b)(6) last year on (b)(6) 2019.One optometrist i visited recently was shocked that anyone is still using microkeratomes to cut lasik flaps as opposed to the newer femtosecond lasers, almost all lasik surgeons are now using and thought it might be a contributing factor to my symptoms.I have been struggling with various vision problems ever since that i never experienced before surgery, including: 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, i will see their outline glow.On a pure black oled screen (black pixels emit no light) displaying 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.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.My vision in low light settings is just generally worse.In dimly-lit settings such as a party indoors i find it harder to focus on people's faces at a medium distance away from me; my depth perception feels off and their outline seems to blend into the background more.This makes social situations harder to navigate.Dr (b)(6) overcorrected my vision and i am now slightly farsighted.As a result, reading text on screens is now less comfortable/more strain inducing than it ever was in glasses.Kind of a problem when your job involves doing this for 8+ hours a day 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.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 8+ inches 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.My wife and i had a baby not long after i had lasik and it's a bit heartbreaking to not be able to see her face clearly when i'm holding her up on my shoulder.I know that had i not had lasik, i would have been able to see her in this case.Car headlights/street lamps/etc at night now have a distracting starburst effect that makes it harder to drive safely.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.Fda safety report id# (b)(4).

• Brand Name: ML7 MICROKERATOME
• Type of Device: KERATOME, AC-POWERED
• Manufacturer (Section D): MED-LOGICS, INC.
• MDR Report Key: 10476787
• MDR Text Key: 205339829
• Report Number: MW5096346
• Device Sequence Number: 1
• Product Code: HNO
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ML7
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 35 YR