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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC, INC. ZEISS VISUMAX; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
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CARL ZEISS MEDITEC, INC. ZEISS VISUMAX; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Pain (1994); Visual Disturbances (2140); Halo (2227); Anxiety (2328); Discomfort (2330)
Event Date 05/10/2017
Event Type  Injury  
Event Description
Following a lasik procedure with the zeiss visumax femtosecond and nidek ec-5000 excimer lasers, i developed persistent and chronic dry eye, floaters, halos, starburst, glare, and poor night vision in both eyes.I did not previously experience any of these issues prior to surgery.My surgeon claims these side effects are extremely rare and/or unrelated to my surgery, claims that other ophthalmologists have confirmed are untrue.Currently at about 3.5 years after surgery, these symptoms have only become worse with time.These symptoms have caused persistent anxiety, pain, and discomfort, adversely affecting my everyday function, ability to work, quality of life, mental health, and general well-being.Aside receiving medical treatment for these symptoms which are chronic and incurable, i also require behavioral therapy to maintain my well-being.Floaters in both eyes noted by several ophthalmologists, from 2018-2019.Fda safety report id# (b)(4).
 
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Brand Name
ZEISS VISUMAX
Type of Device
FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Manufacturer (Section D)
CARL ZEISS MEDITEC, INC.
MDR Report Key10507247
MDR Text Key206325142
Report NumberMW5096471
Device Sequence Number1
Product Code OTL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/03/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age30 YR
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