VISUMAX FEMTOSECOND LASER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-12 for VISUMAX FEMTOSECOND LASER manufactured by Carl Zeiss.

Event Text Entries

[57583221] I had surgery on both of my eyes with relex smile technique (visumax femtosecond laser). My graduation was left eye -6. 0 and right eye 0. 5 of myopia. After the surgery, i experienced many side effects that haven't been solved until today. These side effects include: severe dry eye, blurred vision, occasional eye pain, severe black spots, blepharitis, keratitis. I have chronic damages in my eyes and i need to take medication. Plasma rich in growth factors (prgf), probably for the rest of my life. The surgeon didn't prevent me from all these risks, or at least, he was not clear about the high incidence of these risks, so i feel completely deceived.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5065389
• MDR Report Key: 6030313
• Date Received: 2016-10-12
• Date of Report: 2016-10-12
• Date of Event: 2015-01-29
• Date Added to Maude: 2016-10-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: VISUMAX FEMTOSECOND LASER
• Generic Name: VISUMAX FEMTOSECOND LASER
• Product Code: OTL
• Date Received: 2016-10-12
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: CARL ZEISS

Device Sequence Number: 1

• Brand Name: VISUMAX FEMTOSECOND LASER
• Generic Name: VISUMAX FEMTOSECOND LASER
• Product Code: HQF
• Date Received: 2016-10-12
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARL ZEISS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2016-10-12