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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX FEMTOSECOND LASER; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
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CARL ZEISS MEDITEC AG (JENA) VISUMAX FEMTOSECOND LASER; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Patient Problem Loss of Vision (2139)
Event Type  Injury  
Event Description
I've come across doctors that use the visumax 500 laser eye surgery equipment in ways that are not approved by the fda.I'm writing to bring to light two issues: the first issue is that these doctors both have websites that either state or suggest that the procedure of keratopigmentation is safe and proven, and i've learned that many of their patients have experienced issues after the surgery that the doctors are not addressing, nor warning them about it prior to the procedure.Some have even lost some of their eyesight due to this procedure.This form is not allowing me to share the website that is advertising this procedure, but if you perform a google search of (b)(6) lasik eye color change, the site mentioning keratopigmentation is the one that i am referring to.It has the doctor's information, as well as the sites where these procedures are done.The second issue is that i've also received complaints from one of the offices that perform these procedures that the doctor will say he's performing smile (a laser eye correction surgery), and instead performs lasik without telling the patients, in order to charge the patient more.This isn't a misuse of the equipment, instead it's what i think is best described as a con.Reference reports: mw5148268, mw5148269, mw5148270, mw5148272.
 
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Brand Name
VISUMAX FEMTOSECOND LASER
Type of Device
FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Manufacturer (Section D)
CARL ZEISS MEDITEC AG (JENA)
MDR Report Key18169528
MDR Text Key328532687
Report NumberMW5148271
Device Sequence Number1
Product Code OTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Patient Sequence Number1
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