Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY LASIK; LASER SYSTEM
  • 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
 

LASIK SURGERY LASIK; LASER SYSTEM Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Dry Eye(s) (1814); No Code Available (3191)
Event Date 02/01/2013
Event Type  Other  
Event Description
Lasik surgery both eyes, no problems with pre procedure dry eyes.Now 16 months later, severe dry eye continues.I awaken with eye lids unable to open, sticking to eye ball, i require eye drops to separate eye ball from eye lids to open.I used eye drops all day long.My vision fluctuates all day long even with bilateral duct plugs.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LASIK
Type of Device
LASER SYSTEM
Manufacturer (Section D)
LASIK SURGERY
MDR Report Key3885757
MDR Text Key4647877
Report NumberMW5036680
Device Sequence Number1
Product Code LZS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
-
-