MAUDE Adverse Event Report: FEMTOLASIK; EXCIMER LASER SYSTEM

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).

• Brand Name: FEMTOLASIK
• Type of Device: EXCIMER LASER SYSTEM
• MDR Report Key: 12699189
• MDR Text Key: 278427705
• Report Number: MW5104953
• Device Sequence Number: 2
• Product Code: LZS
• Reporter Country Code: EZ
• Number of Events Reported: 1
• 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 Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CONCOR 5MG; LEXAURIN 1.5 MG; TRITTICO 75MG
• Patient Outcome(s): Disability
• Patient Age: 27 YR
• Patient Weight: 88