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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Burning Sensation (2146)

Event Date 07/04/2018

Event Type  Injury  

Event Description

I accepted smile lasik and collagen cross linking together in an international eye center located in (b)(6) on (b)(6) 2018.Since the day i accepted the surgery, problems came out, my eye sight can't be corrected to 1.0, my left eye can only see 0.5, right eye 0.6.My left eye is totally nearsighted, but my right eye is nearsighted but also longsighted.I can't see either far or close.This makes my eye can't focus together, i can't use my eyes at all, if i see things for few mins, i get headache, nausea and want to vomit.More terrible thing is that my eye vision sucks as hell, double sight, blurry, ghosting, glare, starburst, seeing shadows under things all the time, when i stay inside building or places a little dark, all these symptoms get much worse.Some drs told me this is irregular astigmatism which can't be corrected by any glass.Besides i have extremely dry eye, my eyes always feel burning and no matter how i use eye drop it doesn't work.Also eye pain which i don't know the pain is from inside or something.It's like something pulled deeply in my eye or scratching pain from the surface and the pain spreads to my face and ear.That's killing my life.Besides, i see floaters covered full of my eyeballs.The ectasia also happening in the posterior cornea of my right eye, so the astigmatism is still increasing.All the side effects i'm suffering makes me want to kill myself, i can't live a normal life, i'm only (b)(6) still studying in college.This surgery totally ruins my life.Actually i'm (b)(6).I just see a bunch of people in (b)(6) suffering the same things as i do.You really know how much people having side effects in (b)(6) or in (b)(6)? i joined a lot of lasik groups in (b)(6), a lot of terrible side effect cases being shared everyday, if you want to see, i can send you over ten thousands of these cases.These so-called drs making this harmful refractive surgery to people without knowing ways to cure the side effects.How many eyes or lives are you still allowing this surgery to ruin? if any of you are human with any conscience please, stop this harmful surgery, you guys must put into research how to cure our damaged eyes right away.For there are hundreds of thousands of pairs of damaged eyes in china or more in asia waiting to be fixed.Reason for use: to get off my glasses.

• Brand Name: VISUMAX FEMTOSECOND LASER (SMILE)
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA)
• MDR Report Key: 8106079
• MDR Text Key: 128577189
• Report Number: MW5081613
• Device Sequence Number: 2
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/24/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 21 YR
• Patient Weight: 44