MAUDE Adverse Event Report: LASIK

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dry Eye(s) (1814); Depression (2361)

Event Date 07/20/2011

Event Type  No Answer Provided  

Event Description

I had lasik on (b)(6) at laser vision (b)(6), the doctor was (b)(6).I was (b)(6).On (b)(6 ) 2014 i have been diagnosed with severe dry eye due to the surgery.I am on depression with suicidal thoughts.(b)(6).

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 3972765
• MDR Text Key: 4754858
• Report Number: MW5037511
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 28 YR
• Patient Weight: 50