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

MAUDE Adverse Event Report: ZIEMER GROUP FEMTO LDV FEMTOSECOND LASER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

ZIEMER GROUP FEMTO LDV FEMTOSECOND LASER Back to Search Results
Event Date 05/01/2010
Event Type  Injury  
Event Description

Lasik eye surgery. Abstract of case report published online. (b)(4) idiopathic peripheral necrotizing keratitis after femtosecond laser in situ keratomileusis. J cataract refract surg on (b)(6) 2012. The authors report a case of necrotizing peripheral keratitis after lasik using the femto ldv femtosecond laser in a (b)(6) with no history of medical or ocular disease. The severe peripheral flap inflammation resulted in stromal necrosis. Published photographs reveal a "scalloped appearance" at the flap margin where the cornea melted in both eyes. (b)(6), md of (b)(6) laser vision in (b)(6) is named as the surgeon (b)(6).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFEMTO LDV
Type of DeviceFEMTOSECOND LASER
Manufacturer (Section F)
ZIEMER GROUP
Manufacturer (Section D)
ZIEMER GROUP
Device Event Key2518767
MDR Report Key2493072
Event Key2389805
Report NumberMW5024639
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 02/10/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Is the Device an Implant? No
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 02/10/2012 Patient Sequence Number: 1
-
-