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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX VISX STAR S4

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VISX VISX STAR S4 Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Blurred Vision (2137); Visual Impairment (2138); Halo (2227); Disability (2371)
Event Date 03/26/2010
Event Type  Injury  
Event Description

Please help me. My vision has been permanently damaged and there are no resources to help me. This procedure has robbed me of happiness and the ability to participate in the hobbies and activities i was engaged in prior to having lasik. My poor vision also impacts my ability to perform my job as a (b)(6). There is no way to describe what it is like living with vision like mine. My life is falling apart because of this completely unnecessary procedure. The worst part about it is i am unable to be the husband to my wife that i vowed to be 9 years ago. My wife's mother was murdered when she was younger and her father was never really there for her. Now she is losing her husband too because i am losing the ability to cope with my vision. I am also afraid that you (fda) do not receive reports of negative lasik outcomes, because the report format on the following pages asks for info that most individuals do not have or is not applicable to a negative lasik event. A simplified format would improve pt responses. On (b)(6) 2010, i had my first lasik consultation with (b)(6), at (b)(6). At this consultation after all screening was completed i spoke with dr (b)(6) and was told i was a candidate for lasik. I spoke to dr. (b)(6) about my concerns of halos, starbursts, higher order aberrations and other vision complications that i had read about. I asked him specifically if i would have any of these issues and he stated that they would be no worse than what i currently experience at my prescription with contact lenses. I was also told that this is no longer an issue with the latest procedures. I did not have any noticeable vision issues prior to having lasik, i also asked dr. (b)(6) if there were differences between the outcomes using a laser or the micro-keratome to cut the cornea flap. He stated that he uses the micro-keratome as it is more economical because an additional laser is not needed and that the results are the same. I have since found that micro-keratomes are more likely to cause striae which are present in my corneas now after the procedures. I had my pre-lasik appointment on (b)(6) 2010. At this appointment i signed the informed consent and further discussed my additional concerns with dr. (b)(6). One of my additional concerns was listed in the consent form and discussed the eyes being more susceptible to injury after lasik. This was a big concern for me as i was an amateur boxer and was training for the (b)(6) as a personal goal of mine. I do not remember exactly what was said to me by dr. (b)(6), but it must have been to the effect that it would be ok to continue boxing after the procedure as i went through with the procedure and would not have otherwise as competing was a very important goal for me. I also expressed this concern to dr. (b)(6) (surgeon that performed both the lasik and lasik re-treatments at dr. (b)(6) office) prior to the first surgery and was told it would not be an issue. I have also found that the fda website states you are probably not a good candidate if you participate in contact sports and boxing is listed first on the list. I also spoke to dr. (b)(6) about a statement that lasik is to "reduce your dependence on glasses or contacts" and told him that if there was a real risk that i could still need contacts after the procedure that i was not interested. Again, i do not recall exactly what his response was, but i went through with the procedure, so i must have been left with little doubt there would be any issues. On (b)(6) 2010, i had the first lasik surgery on both eyes. Prior to the procedure i asked dr. (b)(6) if this procedure would have any impact on my participation in boxing and he said no. He went on to explain that a boxing glove was a big, blunt object and it would not damage my eye after the surgery. I was unable to ask the surgeon (dr. (b)(6)) any questions until after i had taken the valium which is troublesome. The valium greatly reduced my anxiety about the procedure which may have also led me to backing out once i had a chance to speak further with the surgeon as this is the first time i have had an opportunity to ask the surgeon any questions. On (b)(6) 2010, this was my first follow up appointment. I drove to this appointment, as i was told the day of the surgery i would be able to see well enough to drive. At this appointment i told the dr (different doctor i had not previously met) that i was unable to see well and was scared driving to my appointment. I later found out that my vision was 20/70 which is not legal to drive. I was never informed of this. From (b)(6) 2010, i suffered from severe vision issues including constantly fluctuating vision, blurred vision, halos, starbursts. And multiple images in each eye. During this time, starting a month or two after the first surgery my vision did seem "perfect" for a few minutes each morning. My vision would then decline throughout the day and all of the multiple images, blurriness, halos, and starbursts would increase. Dr. (b)(6) was never able to explain why this would occur. On (b)(6) 2010, i had the lasik re-treatment performed on both eyes. Again, i did not get an opportunity to speak with the surgeon until after i was given the valium. From (b)(6) 2010 to present, i still suffer from the multiple images in each eye, halos, starbursts, fluctuating vision, and have had a dull ache in my right eye since the re-treatment.

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Brand NameVISX STAR S4
Type of DeviceVISX STAR S4
Manufacturer (Section D)
MDR Report Key2240760
MDR Text Key2174809
Report NumberMW5022138
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 09/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2011
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
Was the Report Sent to FDA? No

Date Received: 09/03/2011 Patient Sequence Number: 1