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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN RELEX SMILE; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

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UNKNOWN RELEX SMILE; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dry Eye(s) (1814); Itching Sensation (1943); Keratitis (1944); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Burning Sensation (2146); Halo (2227)
Event Date 07/03/2018
Event Type  Injury  
Event Description
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.
 
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Brand Name
RELEX SMILE
Type of Device
FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Manufacturer (Section D)
UNKNOWN
MDR Report Key8403457
MDR Text Key138442629
Report NumberMW5084752
Device Sequence Number0
Product Code OTL
Combination Product (y/n)N
Reporter Country CodeKU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age27 YR
Patient Weight50
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