MAUDE Adverse Event Report: LASIK

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Blurred Vision (2137); Loss of Vision (2139); Halo (2227)

Event Date 06/07/2012

Event Type  Injury  

Event Description

I had lasik surgery at (b)(6), that the surgeon said was successful.When i returned the next day for follow-up, i was told everything went well.A week later at a subsequent follow-up, i complained that i could not see out of my left eye.The nurse, (b)(6), said to me that the vision was probably overcorrected, and i would need surgery again.When the doctor came in, she said there was no overcorrection; i just needed time to heal.A month later, i complained about the same problem, and was told again that i just needed to heal.I was charged (b)(6) for temporary glasses to use until my eye healed.Two months later, at the next follow-up, i said again that vision was blurry out of my left eye, but again i was told that the surgery was successful and that i just took longer to heal than normal.I was scheduled for another follow-up 6 months later.I began to experience starburst, halos, double-vision, blurred vision, and severe headaches.I made an appointment with an ophthalmologist on (b)(6) 2013, who advised that because the corrected vision was so different in each eye -1 in the right, -4.75 in the left, i would need glasses again to alleviate the symptoms and to see clearly.

• Brand Name: LASIK
• MDR Report Key: 3202328
• MDR Text Key: 3473753
• Report Number: MW5030724
• 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: 06/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 66