MAUDE Adverse Event Report: PRK SURGERY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Scarring (2061); Seizures (2063); Visual Impairment (2138)

Event Date 12/17/2011

Event Type  Injury  

Event Description

I had prk surgery on both eyes in 2001 while on active duty, (b)(6).Had to undergo it several months later due to scarring.Noticed i had to wear sunglasses at all times after that and my night/low light vision was greatly diminished.Started getting migraine headaches.Symptoms progressed till in (b)(6) 2011 i woke up in the emergency room of an apparent seizure.This occurred again in (b)(6) 2012 and i was then diagnosed with seizure syndrome.My left eye lid sticks to my eyeball at night which triggers the seizure and causes extreme pain in that eye and a migraine headache.My short term memory is worsening.I am now on blood pressure meds.I have lost my job due to this.Even with the seizure meds i sometimes have painful nightly episodes of these side effects.

• Brand Name: PRK SURGERY
• Type of Device: PRK SURGERY
• MDR Report Key: 5535571
• MDR Text Key: 41519176
• Report Number: MW5061340
• 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: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 53 YR
• Patient Weight: 77