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

MAUDE Adverse Event Report: VISX CUSTOM VUE LASIK

  • 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 CUSTOM VUE LASIK Back to Search Results
Event Date 10/11/2007
Event Type  Injury  
Event Description

Laser assisted in-situ keratomileusis - visx customvue customized corneal lasik post-op problems persisting to the present - (b) (6) 2010-: -persistent eye pain in left eye -persistent dry eye unrelieved by drops, including restasis -unintended induced monovision from undercorrection of dominant eye. -fluctuating acuity/unstable refraction in both eyes, worse in left eye -persistent light sensitivity in both eyes -ghosting, double vision, monocular diplopia -glare, arcs, starbursts, haloes, night vision problems, nocturnal glare -loss of contrast sensitivity -increased floaters -general misery from eye problems. Dates of use: (b) (6) 2007 -- (b) (6) 2010. Diagnosis or reason for use: myopia.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVISX CUSTOM VUE
Type of DeviceLASIK
MDR Report Key1631819
Report NumberMW5015125
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/10/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 03/10/2010 Patient Sequence Number: 1
-
-