MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) RE-LEX SMILE; EXCIMER LASER SYTSEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Keratitis (1944); Pain (1994); Blurred Vision (2137); Loss of Vision (2139); Misdiagnosis (2159); Halo (2227); Weight Changes (2607)

Event Date 07/03/2018

Event Type  Injury  

Event Description

I had gone through the relex smile refractive surgery last year ((b)(6) 2018) because i had myopia of -6.Right after leaving the surgery room everything was blurry and the next day my vision turned white.I was told that i had a visible white haze on my cornea by my family members.Not only was i misdiagnosed by my surgeon but he hadn't mentioned any side effects prior to or after the surgery whatsoever.He only told me that i had a "normal infection" when i visited the next day, and said that it happens with many of his patients and 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 traveled for vacation right after and i had to see several other doctors to finally know a month from the surgery that i had dlk ( deep lamellar keratitis) type 4 and not an infection.Some say i could have ctk (central toxic keratitis) instead.I was informed by some doctors that the lack of lubricating my eyes had made them worse because i have developed eye dryness so doctors i had seen recommended to use lubricating eye drops at all times (which i still currently use).I had been using pred forte and zymaxid like any other lasik patient after the surgery (every 3 hours) and reduced it with time.One of the doctors i had seen recommended doxycycline and i've used it for 3 months but it only gave me a troubled stomach.I do feel a lot better than i had in the 1st 3 months after surgery, but i still see streaks and halos.My eyes are still sensitive to light.My vision is still blurry sometimes but the repetitive images i see are less than before.My vision is not consistent.It changes every now and then and in both eyes i see differently at times.My eyes are also still dry despite the constant lubrication but they hurt less.Sometimes i see different sizes but i have been gradually seeing colors other than greys, blacks and whites.I can read big signs and texts through a large 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.My left eye has more repetitive images although i feel that vision-wise it is better; my right eye's vision quality is less but the repetitive images are "currently" smaller.It used to be the opposite (not constant).I was advised to just wait, because my cornea had become thin after the operation and so none of the doctors recommended cornea transplant operation then and until today 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 simply because none of the doctors know what caused the dlk in my eyes.I would like to know if there are any regulations by the fda for surgeons to inform the patient of all the risks included in the using the relex smile machines.And what are the safety measures for them to take? is having the procedure on one eye at a time considered a safety measure? what are the general practices that surgeons should do before proceeding with the surgery? i gained weight after the surgery from having to stay in the dark for too long (about 6 kilos).Lost my vision.Fda safety report id # (b)(4).

• Brand Name: RE-LEX SMILE
• Type of Device: EXCIMER LASER SYTSEM
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA)
• MDR Report Key: 8645945
• MDR Text Key: 146501121
• Report Number: MW5086919
• Device Sequence Number: 1
• Product Code: LZS
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2019
• 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
• Patient Weight: 51