MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) RE-LEX SMILE; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Device Problem Use of Device Problem (1670)

Patient Problems Keratitis (1944); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Halo (2227)

Event Date 07/03/2018

Event Type  Injury  

Event Description

I have done the re-lex smile refractive surgery because i had myopia of -6 qt (b)(6) centre by dr (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).

• Brand Name: RE-LEX SMILE
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA)
• MDR Report Key: 8590823
• MDR Text Key: 144518258
• Report Number: MW5086435
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: KU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 28 YR