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U.S. Department of Health and Human Services

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

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INTRALASE CORP. INTRALASE FS LASER LASER KERATOME Back to Search Results
Model Number 20003
Device Problem Normal
Event Date 03/27/2007
Event Type  Injury  
Manufacturer Narrative

On 3/06/07 an intralase field service engineer (fse) visited the site and performed scheduled preventative maintenance - no adjustments were required. The following month, an fse returned to site due to dlk report and calibrated z-baseline offset and found the system met specifications and performed as intended upon departure. An intralase clinical applications specialist (cas) has been in contact with the site obtaining patient follow up status and trying to identify a possible root cause. Although a single root cause was not identified, the site made the following changes: introduced use of head coverings for staff, disposable covers for buttons on system which are changed after every procedure, use of different cannulae, speculums, modified energy by 0. 05uj lower and cleaned the humidifier and ventilation system. Since implementation of changes noted above, the site has seen a reduction in dlk cases.

 
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 patient presented with stage 2 diffuse lamellar keratitis (dlk). The patient was prescribed topical and oral steroids. Two days later, the doctor performed a flap lift and rinse. The patient's preoperative best corrected visual acuity (bcva) was 20/12. 5 both (ou) eyes. Postoperative bcva as of the following month was 20/12. 5 ou. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unk.

 
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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 Key844315
Report Number2032002-2007-00051
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/09/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/26/2007
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
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2006
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: 04/26/2007 Patient Sequence Number: 1
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