RE-LEX SMILE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for RE-LEX SMILE manufactured by Carl Zeiss Meditec Ag (jena).

Event Text Entries

[144518258] I have done the re-lex smile refractive surgery because i had myopia of - (b)(6). Right after leaving the surgery room, everything was blurry and the next day my vision turned white. I was told (by my family) that i have had a visible white haze on my cornea while my surgeon said everything was fine and the reason i don't see yet is normal. Not only i was misdiagnosed but my surgeon hadn't mentioned any side effects prior or after the surgery whatsoever. He only told me that i had an infection when i visited the next day, and said that it's normal and happens with many of the pts and said it would disappear within 3 days or so. I wasn't allowed to use lubricating eye drops and my eyes used to hurt so much and be glued together (i wasn't allowed to wash them either). My surgeon had travelled for vacation and i had to see several other drs to finally know after a month of the surgery that i had dlk (deep lamellar keratitis) type 4 and not an infections. Some say i could have ctk (central toxic keratitis) instead. They said it's very rare and it's the first time they see a case like mine with a re-lex smile pt. I was informed that the lack of lubricating my eyes had made them worse because i have developed eye dryness so drs recommended to use lubricating eye drops at all times (which i still currently use). I was also told that my surgeon was supposed to increase the dosage of pred forte and zymaxid and not reduce it like my surgeon had suggestion. I have used them like any other lasik pt after the surgery (every 3 hours) and reduced it with me. Only 1 day after the surgery i was asked to make them every 2 hours (and every hour for 4 days after a month recommended by another dr). One of the drs recommended doxycycline and i've used it for 3 months but it only gave me a trouble stomach. I do feel better than the 1st 4 months after the surgery, but i still see streaks and halos. My eyes are sensitive to light. My vision is still blurry sometimes but with less repetitive images. My vision is not constant, it is still dry despite the constant lubrication but hurts less. I have been gradually seeing colors other than greys, blacks and whites. I can read big signs and texts through a sign font and through devices with a dark background, but i do have trouble reading papers, and when i focus too much, i see more rigid repetitive objects. Texts are never fully clear even the big ones. I was advised to just wait, because my cornea had become thin after the operation and so none of the drs recommended cornea transplant operation at the mean time and i was told that they could look into it after 2 years (it has been 10 months now). However, they did mention that it could be very risky again simply because none of the drs know what caused the dlk in my eyes. Mostly said it could be the type of laser to my body or materials used prior to the operation by the surgeon. I would like to know if there is a principle or protocol for the surgeon using fda approved medical lasik devices to do eyes separately (one eye at a time not both at once to reduce or learn about potential risks), and whether or not protocols exist that obligate surgeons to verbally and in writing mention to the risks of the devices / procedure prior to operating. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086435
MDR Report Key8590823
Date Received2019-05-07
Date of Report2019-05-04
Date of Event2018-07-03
Date Added to Maude2019-05-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
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 Report3

Device Details

Brand NameRE-LEX SMILE
Generic NameFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Product CodeOTL
Date Received2019-05-07
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS MEDITEC AG (JENA)


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2019-05-07

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