MAUDE Adverse Event Report: CARL ZEISS RELEX SMILE; LASER OPHTHALMIC

Device Problem Insufficient Information (3190)

Patient Problems Visual Impairment (2138); Visual Disturbances (2140)

Event Date 02/15/2018

Event Type  Injury  

Event Description

I had smile surgery for my eyes.The surgeon's name is dr (b)(6).He did the treatment area (optical zone) smaller than my pupil size.My vision is terrible at night and i cannot drive anymore.He lied to me about everything and told me i was risk free.He did not admit his mistake but offered lasik to enhance his mistake.He says i have interface fluid and that's why i have glare during the day as well from reflective surfaces.My vision is especially terrible at night.

• Brand Name: RELEX SMILE
• Type of Device: LASER OPHTHALMIC
• Manufacturer (Section D): CARL ZEISS
• MDR Report Key: 7502156
• MDR Text Key: 108049144
• Report Number: MW5077100
• Device Sequence Number: 0
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: MU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR