• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RELEX SMILE FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Nerve Damage (1979); Pain (1994); Visual Impairment (2138); Halo (2227); Depression (2361); Suicidal Ideation (4429)
Event Date 06/18/2021
Event Type  Injury  
Event Description
Wanting eye refractive laser surgery was the worst decision of my life. Doctors lies about the risks. My name is (b)(6), from (b)(6), premature, expanded limbus, scleratinization, expanded vascularization, astigmatism, smaller eyes, diplopia, strabism, and lazy right eye. Right eye -5. 0, -1, 25 cyl 25 ax, left eye -5. 75, - 0, 5 cyl 175 ax. At first in (b)(6) 2020 i get relex smile on right eye, during the operation doctor stopped it because of "due to the localization of the entry incision too close to the limbus, the extraction of the lenticule was not performed. " then i waited 1 month after the eye healed and the doctor suggested femtolasik, in (b)(6) 2020 i get femtolasik, during the operation it was painful and the doctor said that i have the nerves closer to the area where he was working and they would give me more anesthesia but i had to endure it, after that its disaster. They removed all my diopters, but left astigmatism and caused high order aberrations, probably damaged some nerves. Even after 1 year i have all side effects - hoa, like big starbursts even in daylight, halos, ghosting. Double text in left eye, bad night vision, dry eyes. My vision is cloudy with many irritating floaters, not sharp, i don't focus on details, but i can read. After few months my vision are greyish, low contrast a have problems with shades of black and grey. According to doctor i have absolute vision and its considered as success operation. Thought of suicide. Now i takes medications for depression. I was supposed to have a strabismus operation. A year ago it looked like it would be possible, but the lasik somehow shifted my eyes and the strabismus can't be fixed anymore. That's bad, because i had to tilt my head upwards because of the squinting of my right eye and now i have neck pain because of it. They butchered me in (b)(6). Doctors who butchered me are (b)(6). Their poor judgment during the examination led to the approval of the operation. Prof. (b)(6) who proposed femtolasik after the unsuccessful relex smile surgery, and (b)(6) who performed both operations. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRELEX SMILE
Type of DeviceFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
MDR Report Key12699189
MDR Text Key278427705
Report NumberMW5104953
Device Sequence Number1
Product Code OTL
Reporter Country CodeEZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/25/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/26/2021 Patient Sequence Number: 1
Treatment
CONCOR 5MG; LEXAURIN 1.5 MG; TRITTICO 75MG
-
-