RELEX SMILE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for RELEX SMILE manufactured by Unknown.

Event Text Entries

[138442629] Done the relex smile surgery. My surgeon mentioned no side effects whatsoever. He saw me monday night (b)(6) 2018 and told me he can perform it the next day and that i am eligible. I was nervous and scared. The operation was very annoying but didn? T take long. I wasn? T put at ease throughout. When it was over, i was seeing a blur. He told me to go home and rest and come within 2 days. Gave me pred forte to be used every 3 hours along with zymaxid. At home, i tried to keep my eyes shut the whole time. The medications felt like there was sand in my eyes and it was itchy and i felt heat coming out of my eyes (had this issue for several months). I was in pain and when i saw him for the 1st time after the operation, he said it? S a normal infection, it should disappear within a couple of days, i just need to increase the dosage of pred forte and zymaxid to every 2 hours instead of 3 for the next day and then go back to the same dosage until he sees me 3 days later. Through those days i couldn? T sleep or open my eyes from the time i woke up. They were glued together (i was asked to keep them away from water) and i didn? T have any lubrication drops to use because he didn? T tell me i should use them. I tried to call the clinic to ask if i can use lubricating drops because i was suffering but i was put on hold several times and finally i was told since i have an infection i shouldn? T use any lubricating drops until my next appointment. My appointment was 11 days after the operation. When i visited, my surgeon had traveled so i was transferred to another doctor who was with him throughout the operation. He reduced the pred forte and zymaxid to 4 times a day and i told him about the pain and dryness and that i can? T see or be near any light. He added the lubricating drops and asked me to use them at least 6 times per day and said i have dryness now. After seeing him my vision was not improving and i was worried for i was told that my vision is 30% and will be 60% the week after and i had to work and travel 3 weeks before the operation (my surgeon had known about this before proceeding with the operation). I wasn? T able to drive or read or see anything; it was a blurred vision with halos and ghosts and i had to be in the dark and it was dry and painful. When i visited 5 days later, the other doctor had also traveled! And so i? Ve seen another doctor in the same clinic who had told me that she doesn? T think that what i have is normal or that it? S an infection so she suggested i decrease the medication to 3 times a day not 4 and transferred me to another dr. At the same clinic who had later diagnosed me with dlk. He said it was stage 3 or 2, he wasn? T sure so i started seeing 14 other doctors because i lost trust and basically lost my vision and no one seemed to know what was wrong. The clinic i? Ve done the surgery in was in (b)(6), my home country, and i think the relex smile operation is only available at my surgeon? S clinic. The other doctors i? Ve seen (locally and abroad) confirmed a dlk stage 4 or a ctk, and said there is nothing to do now because my cornea is very thin after the operation and that if there is anything they could do it's either create specific lenses or implant a cornea but that should be done in a year or 2. It has been 8 months. I was able to see the red color with time along with other colors. I still mistake some colors and it's sad and embarrassing but it's only because i can? T differentiate them. I still can? T read anything on paper unless the sign or text is extremely huge and preferably with a dark background. I see halos and a month ago i started seeing streaks as well. My vision fluctuates. I see differently in both eyes. I still can? T drive. I still wake up with dry eyes (have used other medication to help with time and still use lubricating drops). I still see shadows and haven? T seen my face in so long. I? Ve used doxycycline for 3 months but it developed problems with my stomach so i stopped. I still suffer from my vision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084752
MDR Report Key8403457
Date Received2019-03-07
Date of Report2019-03-05
Date of Event2018-07-03
Date Added to Maude2019-03-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameRELEX SMILE
Generic NameFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Product CodeOTL
Date Received2019-03-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerUNKNOWN

Device Sequence Number: 1

Brand NameRELEX SMILE
Generic NameFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Product CodeOOE
Date Received2019-03-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2019-03-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.