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Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Disability (2371)
Event Date 07/02/2010
Event Type  Injury  
Event Description

Had lasik performed at (b)(6) in (b)(6) on (b)(6) 2010. After my procedure, my night sight was very foggy, large halos, large starbursting, and degraded vision in dim lighting. Pupils were not measured pre-surgery, and i didn't find out until after i started noticing problems. My pupils after surgery were measured at 8. 5 mm and the optical zone used was 6. 5 mm, transition 1. 25 mm and blend zone out to 9 mm. Below is a letter i wrote to the medical director there. Mr. (b)(6), i am writing you today to ask for a little help. So far i still have massive starbursting, glare, loss of contrast in dim light, and ghosting just to name a few. In my pre op visit, my pupils were never measured with the colvard pupillometer like when i had them remeasure them in (b)(6). In fact i don't ever recall them being measured. It's hard to believe that on my charts they are said to be 6 mm but when i had them remeasured in fact they were over 8 mm which explains why all my vision problems are at night and in poor lighting when my pupil dilates. Its really not rocket science to understand that. Even my regular ophthalmologist said that my pupils are really big and another ophthalmologist i just recently saw measured my pupils at 8. 6 mm. He told me that lasik should have never been performed on me because of the large pupils. So far i haven't gone out anywhere with my kids at night. I've been stuck inside my house because of the night time disturbances. My wife has to take them everywhere at night because it gets hard to drive. The alphagan p drops work sometimes but then tend to lose effectiveness over a few nights. I know that there is "research" that says that pupil size doesn't matter and all that, but most of it is "independent research" which pretty much means that it's worthless information. I was even told by staff that my pupils dilate past the treated area and it will go away when i get older. I'm not going to wait 10-15 years to play the let's wait and see game. This has directly effected my income, quality of life and mood. The staff have been nothing but nice to me so i'm not complaining about that. My next step i'm going to take to solve my issues is having a mini-scleral lens made to correct the night time issues. I've already been to an appointment with dr. (b)(6) in (b)(6) to be fitted for some contacts to wear at night at the cost of (b)(6). I could have an enhancement for my left over prescription of -. 50 in my left eye but to take the risk of being overcorrected and then trading one problem for another one i've pretty much talked myself out of that. Would it help with my night issues? no. Unless they could enlarge the optical zone, but that's another surgery and no guarantee. Last time i checked i only have one set of eyes to work with and they are how i view the world. I've tried wearing a contact lens and glasses but they don't help with the night issues, so another surgery wouldn't help. I would like a little help on paying for these lenses that way i can get back to a normal life and enjoy night time activities, but i doubt that will happen. I can only wish. My other question i have are: if pupil size doesn't matter, why are they administering a drug that constricts pupils after refractive surgery? just in my opinion, you cannot acknowledge the reality of "night myopia", which affects unoperated eyes with large pupils, and at the same time, deny that pupil size is unimportant in lasik. Night myopia is real, and large pupil-related night vision problems after lasik is real. Thanks for you time. Thanks, (b)(6).

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Type of DeviceLASIK
MDR Report Key2037665
MDR Text Key1892811
Report NumberMW5020013
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

Date Received: 03/29/2011 Patient Sequence Number: 1