VISUMAX FEMTOSECOND LASER (SMILE)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for VISUMAX FEMTOSECOND LASER (SMILE) manufactured by Carl Zeiss Meditec Ag (jena).

Event Text Entries

[128577189] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081613
MDR Report Key8106079
Date Received2018-11-26
Date of Report2018-11-24
Date of Event2018-07-04
Date Added to Maude2018-11-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 Report0

Device Sequence Number: 1

Brand NameVISUMAX FEMTOSECOND LASER (SMILE)
Generic NameFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Product CodeOTL
Date Received2018-11-26
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS MEDITEC AG (JENA)

Device Sequence Number: 2

Brand NameVISUMAX FEMTOSECOND LASER (SMILE)
Generic NameFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Product CodeOTL
Date Received2018-11-26
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerCARL ZEISS MEDITEC AG (JENA)


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Deathisabilit 2018-11-26

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