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

MAUDE Adverse Event Report: LASIK LASIK SURGERY

  • 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 LASIK SURGERY Back to Search Results
Event Date 11/30/2009
Event Type  Injury  
Event Description

I had lasik surgery on one eye. On the second day postop, i developed a condition called diffuse lamellar keratitis. Treatment was started of hourly steroid drops and other eye drops. A few days later, the flap had to be lifted again and the eye flushed out to remove this debris. It is a month later, and i still have the condition greatly affecting my vision. Sometimes impossible to see clearly. This is a much more prominent side effect of lasik than is being reported! it is a dirty little secret that is not disclosed prior to surgery!! this condition has the potential of permanently scarring the cornea and causing blindness. Please investigate and insist all cases must be reported!!.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLASIK
Type of DeviceLASIK SURGERY
MDR Report Key1580957
Report NumberMW5014359
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/12/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 01/12/2010 Patient Sequence Number: 1
-
-