MAUDE Adverse Event Report: LASIK EYE CENTER LASIK PLUS

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Anxiety (2328); Depression (2361)

Event Date 01/06/2010

Event Type  Injury  

Event Description

I had lasik eye surgery at lasik plus and my life hasn't been the same since. Suicidal and etc now.

• Brand Name: LASIK PLUS
• Type of Device: LASIK PLUS
• Manufacturer (Section D): LASIK EYE CENTER
• MDR Report Key: 3370439
• Report Number: MW5031983
• 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: 09/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Patient Age: 21 YR
• Patient Weight: 79
• Patient Outcome(s): Other