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Model Number STAR S4
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Corneal Abrasion (1789); Vitreous Floaters (1866); Visual Disturbances (2140)
Event Date 02/09/2010
Event Type  Injury  
Event Description
I have had two lasik surgeries performed at (b)(6). The optometrist was (b)(6), od and the ophthalmologist was (b)(6), md for both surgeries. The timeline for the surgeries is: (b)(6) 2010 initial consultation with (b)(6), od (b)(6) 2010 pre-lasik measurements taken (b)(6) 2010 first lasik surgery both eyes performed at (b)(6), md (b)(6) 2010 lasik treatment surgery (both eyes) performed at (b)(6), md. On (b)(6) 2010, i received a written price quote for "custom" lasik. They did not perform custom lasik custom vue. I have copies of my operative reports indicating i received "conventional" lasik in (b)(6) 2010. This is fraud! furthermore, using word combination like "custom lasik" when the svs provided are custom vue lasik or a conventional lasik is misleading and deceptive. I was not a candidate for lasik due to my active participation in boxing. (b)(6), od and (b)(6), md were both informed of my participation in boxing prior to performing the surgeries. I would not have signed the informed consent had dr (b)(6) indicated that it would no longer be safe. Dr (b)(6) also assured me that continuing to participate in boxing would be safe. Dr (b)(6) and staff did not maintain accurate records of my medications. At a later date, i requested that (b)(6), od pull my records to review them with me and he would not, even though the computer was within arms length. (b)(6), od and (b)(6) md provided false or misleading info on their websites. (b)(6) website (b)(6) specifically states lasik is a cutting edge procedure for improving vision and getting rid of glasses or contacts forever. (b)(6), od orally provided statistical data that directly correlated with custom vue results from his website. Their website has changed and the address is no longer valid, (b)(6). The title stated "updated customvue results" in large, bold lettering, however, the small print at the bottom of the chart states the data is from 2004. This data excluded my degree of required correction, and therefore, did not provide any indication of what i could expect as an outcome. Lasik procedures induce higher order aberrations. Many pts have 20/20 visual acuity, but suffer from double vision, halos, starbursts, etc that significantly reduce their vision quality. Advertising success in terms of visual acuity 20/20, 20/40, etc is deceptive. I was a high risk pt likely to experience night vision issues including: halos, starbursts, and multiple vision due to my high degree of correction and large pupil size. I was not informed of this until after the first surgery. I asked (b)(6) directly if i would have any of the night vision issues listed in the informed consent because i was scared of having damaged night vision as i spend a significant amount of time in dim or dark lighting conditions. (b)(6), od informed me that these side effects are no longer an issue with the latest procedures. Prior to lasik i did not have any vision issues in dim or dark lighting conditions. My pupils measured as large as 7. 9 mm. I was given expired prescription eye medication by (b)(6), md and instructed to use the medication for six months before i would see an improvement. I was never previously diagnosed with a medical condition warranting the use of this medication, even though i had been seen by many optometrists and ophthalmologists prior to dr (b)(6) giving me this medication. I have both the medications and the dated dosage instructions as evidence. I was given a prescription eye medication, pilocarpine, by (b)(6), md that was not intended for use outside of dr (b)(6) partner, office. It was labeled "for office use" and did not have my name on the bottle or packaging. I have this medication and its packaging as evidence. This medication was prescribed to reduce my pupil size, because i was experiencing vision problems due to the high degree of correction and large pupil size. My vision was not stable at the time i received the second surgery. My vision fluctuated greatly throughout each day. The surgery has induced a significant number of vitreous floaters in both of my eyes that were not present prior to the surgeries. This side effect was not disclosed to me prior to either surgery. This was referred to as "the fleas of everyone's vision" by dr (b)(6) when i discussed the issue with him. Floaters were not the fleas of my vision, but surgically induced damage to both of my eyes. Both surgeries were performed within view of the lobby. There was a seating area designated for spectators. This practice gave the false appearance that the surgery was safe and without risk. I was not informed prior to the first surgery that the corneal flap can be easily lifted during the first two years, and in many cases lifted after several years. This one sentence would have immediately caused me to decline the procedure. This was disclosed to me six months after the initial surgery, in the second consent form before my re-treatment. This is info that could reasonably cause a large population of potential pts, including myself, to decline having the surgery. The corneal flap does not "heal" in the same manner as the general population defines healed. For example, a healed cut on one's arm after surgery cannot be easily reopened for years following the surgical procedure. I would not have accepted this side effect under any circumstance. The higher the attempted correction, the longer it takes the cornea to heal. This too would have caused me to decline the surgery. My wife and i had vacation plans shortly after my initial surgery date. An important vacation with my wife was ruined due to my poor vision. My quality of life has been destroyed because of a useless, elective surgery. My professional career as a mechanical engineer will be in jeopardy if my. I can provide electronic scans of the majority of my medical records including wavefront measurements, multiple hospitalization records for attempted suicide and depression, informed consent forms from both lasik procedures, operative reports for both procedures, etc. Many items are shown on my personal website (b)(6). Prior to lasik, i did not have depression or any other mental health related issues. I also did not have any vision problems before having lasik. I was healthy and actively participated in amateur boxing. My career was also going extremely well. Lasik has changed all of this and created a hardship for my wife and i. I have spent thousands of dollars as a direct result of lasik related complications to my vision and overall health. I have had continuous issues with my vision and have not had a single day of clear, normal vision since the first lasik surgery on (b)(6) 2010. I have to use alphagan p daily to reduce my pupil diameter to see better in dim/dark lighting conditions. I also have to use steroid eye drops periodically to help resolve recurrent corneal erosions as a result of the lasik procedures. My contact lenses do not correct my vision and cost much more. Prior to having lasik i did not have any issues with my vision.
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Type of DeviceVISX STAR S4
Manufacturer (Section D)
MDR Report Key2578614
MDR Text Key2634854
Report NumberMW5025398
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/12/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSTAR S4
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/12/2012 Patient Sequence Number: 1