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

MAUDE Adverse Event Report: INTRALASIK

  • 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

INTRALASIK Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Event Date 06/28/2007
Event Type  Injury  
Event Description

Had lasik surgery in 2007 in both eyes. Left eye problems include massive starbursts at night, halos, dry eye, eye callous, ctk, folds, skin ingrowth near flap, pterygium. Right eye problems severe dry eye, halos, glare, minor starbursts. Lasik re do surgeries (b)(6) 2007, (b)(6) 2007 and (b)(6) 2008.

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceINTRALASIK
MDR Report Key1951972
MDR Text Key1723702
Report NumberMW5018873
Device Sequence Number1
Product Code LZS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/03/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Is The Reporter A Health Professional? No

Date Received: 01/03/2011 Patient Sequence Number: 1