MAUDE Adverse Event Report: CARL ZEISS VISUMAX FEMTOSECOND LASER

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Keratitis (1944); Pain (1994); Blurred Vision (2137); Visual Impairment (2138)

Event Date 01/29/2015

Event Type  Injury  

Event Description

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.

• Brand Name: VISUMAX FEMTOSECOND LASER
• Type of Device: VISUMAX FEMTOSECOND LASER
• Manufacturer (Section D): CARL ZEISS
• MDR Report Key: 6030313
• MDR Text Key: 57583221
• Report Number: MW5065389
• Device Sequence Number: 0
• Product Code: OTL
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ARTIFICIAL TEARS (HYABAK); PLASMA RICH IN GROWTH FACTORS (PRGF)
• Patient Outcome(s): Other; Disability
• Patient Age: 34 YR
• Patient Weight: 56