• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VISX VISX STAR LASER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VISX VISX STAR LASER Back to Search Results
Event Date 06/24/1998
Event Type  Injury  
Event Description

I had two lasik eye surgeries in 1998, using a visx star laser. The surgery was done to correct myopia and astigmatism. The surgery was performed twice on each eye; once in (b)(6) and once in (b)(6). I knew going in that i would need two surgeries because of the extent of my myopia (approximately -12. 50 and -13. 50). Initially, my vision was good following the second surgery. However, my vision has deteriorated in subsequent years and continues to get worse. I have starbursts, halos, glare, and ghost images at night. Neither contacts nor glasses have been able to help these problems. I have recently begun seeing double images, starbursts, and glare sometimes during the day. I don't know what the future holds for my eyes, but i am worried that the deterioration will continue. There seems to be no solution. No one seems to understand the impact that this loss of vision has had on my life. My eye doctor talks as if i should be grateful because using the eye chart i can see around -. 05 in both eyes with a slight astigmatism. However, the crazy images i see have led me to be depressed to the point of considering suicide at times. I have not received a good explanation for why my vision is deteriorating. Three parties were involved in these events: my o. D. , the surgeon, and the center where the surgery was performed. All of my follow up has been with my o. D. Who recommended the surgery and set everything up. I believe they all had my best interest at heart. I report this event not to point fingers at anyone, but to warn others that this surgery has serious risks. I do not want anyone else to go through what i am going through every day, probably for the rest of my life. Dates of use: (b)(6) 1998.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVISX STAR LASER
Type of DeviceLASER
Manufacturer (Section D)
VISX
MDR Report Key2095463
Report NumberMW5020623
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/15/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/15/2011 Patient Sequence Number: 1
-
-