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

MAUDE Adverse Event Report: VISX STAR 3 LASER FOR EYE SURGERY FOR VISION CORRECTION

  • 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 STAR 3 LASER FOR EYE SURGERY FOR VISION CORRECTION Back to Search Results
Model Number STAR 3
Event Date 02/21/2002
Event Type  Injury  
Event Description

Following laser surgery for correction of nearsightedness, pt immediately began to see double when reading or doing other close-up work. A second laser surgery was done on the left eye on (b) (6) 2002, but the double vision problem was not corrected. Pt declined further laser surgeries. Eye tests indicate pt's vision is fine, albeit with some double-sightedness. If the pt reads a book for a while before the eye test, the results are greatly reduced, however, as the double vision in more severe. This double vision is not the result of poor tracking between the two eyes; each eye independently sees double, with the right eye being more extreme. The doctor who did the laser surgery could find no reason for the double vision, although one of his assistants told the pt there was more astigmatism present following the laser surgery than before. Several years later, another doctor said the problem was dry eye and could be corrected with tear duct plugs. Pt allowed temporary plugs to be placed in the tear ducts, but they did not stay long enough to see if there was any benefit. Use of artificial tears does not clear up the double vision. As a result of this complication of the laser surgery, pt has difficulty reading for relatively long periods, and can do so only be gradually squinting more and more at the page and trying to ignore the shadows of the double images. Dates of use: length of surgery on eyes, (b) (6) 2002, length of surgery on eye, (b) (6) 2002. Diagnosis or reason for use: nearsightedness.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTAR 3
Type of DeviceLASER FOR EYE SURGERY FOR VISION CORRECTION
Manufacturer (Section D)
VISX
MDR Report Key1584301
Report NumberMW5014432
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/15/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR 3
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: 01/15/2010 Patient Sequence Number: 1
-
-