MAUDE Adverse Event Report: VISX AMO STAR S4; LASIK SURGERY

Device Problem Incorrect Measurement (1383)

Patient Problems Visual Impairment (2138); Halo (2227); Disability (2371)

Event Date 10/13/2017

Event Type  Injury  

Event Description

I'm a medical student who has been potentially permanently disabled by lasik after being operated by dr (b)(6).After being walked through a series of tests and machines by a tech with little to no explanation or oversight by anyone with medical training.I had a brief sitdown with dr (b)(6) where he looked at my chart for approx 30 secs and said "good, good, good, we can do this, questions." it was never mentioned to me that i was at a much higher risk of developing the severe debilitating low-light symptoms that i developed after the surgery because i was highly myopic.I was never informed until after the surgery that my pupils were actually much larger than the optical zone created by the laser ablation - and for that matter they were incorrectly measured as being smaller than they were in the pre-op evaluation.I was never informed i would not be receiving a "custom" treatment which was heavily advertised on all the brochures, advertisements, discussions etc as well as included within the pricing document presented to me.I experience ghosting of images, halos, starbursts, haziness like being in a fog, and all around just terrible vision that's like looking through the dirtiest contact lens you can imagine.After developing completely terrible vision despite being "20/20", i saw multiple lasik surgeons for second opinions.One said my topography was abnormal like the laser "got hot and didn't ablate this area." dr (b)(6) in response said the surgeon was "reading too much into it." i could not function with this vision and took a leave of absence from medical school, from being at the top of my class.I then tried scleral contact lenses at great personal expense - i could not tolerate these for more than 4 hrs at a time.I went to a surgeon who said my prescription (-8 to -9 with some astigmatism) should have never been treated on the amo visx star s4 that dr (b)(6) used.He said my optical zone was much smaller than the 6mm intended, it was decentered.It was elliptical - all of which contributed to a great proportion of my symptoms.I then received a topography guided retreatment with this dr, again at great personal expense and time commitment, which has improved the symptoms somewhat.Overall i am left visually handicapped for life, mentally scarred, and financially and professionally ruined when i had perfectly fine vision with glasses before the first surgery.The inherent and inevitable risks associated with the surgery were never verbally discussed with me, just briefly glossed over in a multiple page documented full of "legal-ese" style language.The dr operated on my eyes with a laser that should have never been used on it and the outcomes are evident in the abnormally high order aberrations and irregular topography patterns from the first surgery.

• Brand Name: VISX AMO STAR S4
• Type of Device: LASIK SURGERY
• MDR Report Key: 7534376
• MDR Text Key: 108982568
• Report Number: MW5077398
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 24 YR