MAUDE Adverse Event Report: PRK/LASIK

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Pain (1994); Phototoxicity (2165); Disability (2371)

Event Date 09/04/2012

Event Type  Injury  

Event Description

I had prk refractive surgery done in (b)(6) 2012.I have been diagnosed with photophobia.Ever since i have had to use sunglasses pretty much all the time during day time, in sun light, artificial light, during night time, and while driving.I went to my ophthalmologist, and he said that he has never seen a situation like mine.I experience eye pain like a sharp knife stabbed me in my eyes when exposed to light for short periods of time.After exposure for around two hours i start to experience a migraine type headache that obligates me to shut down and take a 2 hour sleep along with at least 800 milligrams of ibuprofen to get rid of the pain.My military career is being seriously affected.My time and activities with my wife and children are being affected.I am forced to wear dark sunglasses all the time, indoors and outdoors.I have read of multiple similar cases like mine after lasik/prk and other eye surgeries.I sometimes take off my sunglasses just to confirm that i am not imagining things, but after a few seconds there is the pain again.I think that the fda really needs to pay attention to this matter and study or suspend this procedure until it has been further studied.

• Brand Name: PRK/LASIK
• Type of Device: PRK/LASIK
• MDR Report Key: 4024389
• MDR Text Key: 20324618
• Report Number: MW5037739
• 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: 08/12/2014

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: 08/13/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 28 YR
• Patient Weight: 86