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

Patient Problem Loss of Vision (2139)

Event Type  Injury  

Event Description

Doctor has a website 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 specific doctor's site is called kerato nyc, and can be found with a simple web search.He is using the visumax system to create a tunnel above the iris in order to inject an unsafe, unproven dye to change the eye color.This tunnel creation with the visumax is intended for icr surgeries to introduce intracorneal rings to flatten the central cornea to correct low levels or myopia.Dr.(b)(6) instead uses these tunnels for the rings to insert a dye.Reference reports: mw5148268, mw5148269, mw5148270, mw5148271, mw5148272.

• Brand Name: VISUMAX FEMTOSECOND LASER
• Type of Device: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA)
• MDR Report Key: 18191707
• MDR Text Key: 328913183
• Report Number: MW5148359
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1