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

MAUDE Adverse Event Report: INTRALASE CORP. INTRALASE FS LASER LASER KERATOME

  • 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
 

INTRALASE CORP. INTRALASE FS LASER LASER KERATOME Back to Search Results
Model Number 20003
Device Problem Normal
Event Date 03/23/2007
Event Type  Injury  
Manufacturer Narrative

On 4/19/07, a field svc engineer (fse) performed preventive maintenance, and the laser maintenance performed as intended, and met specifications. On 5/08/07, an intralase clinical application specialist (cas) visited the site, and performed an investigation in attempt to determine a root cause. Per cas, the surgeon believes the reported issue is related to something in the office and not the laser sys. Surgeon is seeking cas expertise to help identify a root cause. Cas made recommendations regarding potential contributors related to instrument preparation and sterilization practices. The cas did not identify any unusual environmental or surgical technique issues.

 
Event Description

The intralase fs laser was used to create a corneal flap for lasik surgery in 2007, in the left (os) eye. One day postoperatively (the next day), the pt presented with diffuse lamellar keratitis (dlk) with central toxic keratopathy (ctk). The pt was treated with topical steroids. The preoperative best corrected visual acuity (bcva) was 20/20. The pt's current postoperative bcva is 20/40. Add'l info has been requested from the site, but none has been forthcoming. If add'l info is received, a supplemental medwatch shall be filed with fda. The physician does not believe the event is device related.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTRALASE FS LASER
Type of DeviceLASER KERATOME
Manufacturer (Section D)
INTRALASE CORP.
9701 jeronimo road
irvine CA 92618
Manufacturer Contact
mary carvajal
9701 jeronimo road
irvine , CA 92618
9498595230
MDR Report Key861060
Report Number2032002-2007-00054
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/02/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/06/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number20003
Device Catalogue Number20003
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/08/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/06/2007 Patient Sequence Number: 1
-
-