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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASER

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LASER   Back to Search Results
Event Date 04/20/2004
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Over 3 and half years ago, laser eye surgery robbed a boy of his innocence. In 2004 was, by far, the most life altering experience i have ever had. This surgery ruined over 20 years of hard work and dedication. The same year, you performed wavefront guided laser eye surgery on my virgin corneas. At the time, my scoptic pupils were measured at well over 8mm. The optical zone imposed on my corneas for surgery was 6mm. Therefore, you operated on my eyes, knowing that anytime my pupils dilated over 6mm, my eyesight would be worthless. Since no aberrometer at the time of my surgery was able to evaluate corneas over 6 to 6. 5mm, any "blend zone" given on my eyes was worthless. Only 6 of 8. 25mms of my eyes rec'd the full treatment from the surgery. It is my estimate that i spend over 75% of the day with my pupils larger than the given optical zone, thus rendering my vision absolutely worthless the majority of the day. For the rest of my life, i will suffer from pure visual hell. I have severe glare, star bursting, double vision, severely dry eyes, trace cataracts, severe light sensitivity, severe floaters -a result from the combination of pilocarpine and the microkeratome used for the mutilation of my cornea flap-, and a decentered ablation. In addition, within my optical zone, there was an increase in high order aberrations -hoa-, including coma. On top of all this, i now have irregular astigmatism as well. All this is a direct result from the surgery. One can only imagine the psychological side effects this has caused for me. I have since been completely unemployed, as of several months after the surgery. I left to study abroad because i believed you, and even trusted you after my surgery. You told me that another surgery could help. So i waited to be sure, i waited for surgery methods to improve. Instead of working, i went back to school, and tried to read and study as best i could considering the circumstances. I used the motivation of "fixing" my eyes to fuel me through graduate school. I looked forward every day to be "healed. " however, after my arrival back in the u. S. , after being out of the country for one yr, i went directly to your office to hear if you could help me. You said that another surgery could possibly help. You wanted to destroy more of my corneal tissue and perform a surgery to fix what you have caused. Your intention was never to increase my optical zone, which i now know is the real problem which you never admitted to and repeatedly lied about. You said, the typical response that i am "one of the 1 or 2% of post refractive surgery patients with unsuccessful results but keep waiting, your eyes need to heal over time. " real textbook wording on how to avoid a lawsuit and allow my statute of limitations to pass by. Any financial settlement brought about from a litigation case against you would have been fair and just. It would have helped restore some stability in my life and allow me to put myself back on my feet. But your cunning tactics to let the statute of limitations pass me by was remarkable. Through your lies about healing time, to your lies about not knowing the cause of my problems, you covered yourself well. But as a result, you ruined my life and my family's lives as well. I have cut off all contact with my family, since the only emotion i harbor now is depression. I write this letter to you with that same emotion. We both know that there will never be a solution to my problems. With the overwhelming risk of ectasia on my already thinned and weakened corneas, combined with my large pupil size, i will never be a candidate for further surgery. I am forever a prisoner within my body. I have no employment, nor can i maintain employment. I rarely drive, read, write, or do any of the other things i once loved. Having lasik surgery has been the worse mistake of my life. It has literally cost me my life. I have cried every day for over the past 36 months. I have tried several anti depressants without any success since all of these cause mydriasis, making my glare, starbursts, and double vision much, much worse. My life is ruined; unfortunately i am not the only one paying the price. My mother is ill and now her life is ruined. These years were supposed to be the best of my life. I was 20 at the time of the surgery, i wanted to see the world independently and live free. I wanted to be a normal young man. However, i made the mistake of believing and trusting what a dr and his well trained staff told me. I believed a dr who took an oath to do no harm. Even though i signed the consent form, as another lasik victim say "the consent form does not give the dr the right to do surgery on someone who should not have the procedure. " the consent form you sign has you taking all the risks and the dr taking none. I thought that is what i was paying the dr for, his expertise , knowledge and integrity to screen me as to whether i was a good candidate or not. I had a wonderful life and i just now exist from day to day. Before the surgery, i had a huge circle of friends, i no longer have any friends except maybe one and the new friends that i have come to know because they too are lasik casualties. I have not had one happy moment since i started having complications. I am in a severe depression. I have been to my family dr, a grief counselor and a psychologist, nothing helps. Dose or amount: 4 drops. Frequency: daily. Route: occlusive dressing. Dates of use:2004 - 2007; 2004 - 2007. Diagnosis or reason for use: reduce pupil size but caused permanent damage to eye. Event abated after use stopped: no.

 
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Type of DeviceLASER
Device Event Key901192
MDR Report Key926130
Event Key888304
Report NumberMW5003999
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/06/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 10/06/2007 Patient Sequence Number: 1
#TreatmentTreatment Date
PILOCARPINE
ALPHAGAN P
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