MAUDE Adverse Event Report: LASIK

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

After having lasik eye laser surgery, i feel that my vision at night has become terrible. I have also noticed i feel the need for more light to see accurately that the average person. I feel that the lights indoors are never bright enough and i need more light generally to see well.

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 3599054
• Report Number: MW5033995
• Device Sequence Number: 1
• Product Code: LZS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Patient Age: 24 YR
• Patient Weight: 49
• Patient Outcome(s): Other