MAUDE Adverse Event Report: LASIK

Device Problem Insufficient Information (3190)

Patient Problems Eye Injury (1845); Loss of Vision (2139); Visual Disturbances (2140); Disability (2371)

Event Date 07/11/2011

Event Type  Other  

Event Description

I had lasik done at (b)(6) on (b)(6) 2011.After surgery one of my eyes stood out of focus so i was given an enhancement on both eyes which damaged my right eye to where i am partially blind and my left eye requires special contacts to see.I can no longer drive at night due to starburst and shadows from headlights that completely blind me.

• Brand Name: LASIK
• Type of Device: LASIK
• MDR Report Key: 3955753
• MDR Text Key: 19803284
• Report Number: MW5037364
• Device Sequence Number: 1
• Product Code: LZS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2011
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 122