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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 02/23/2007
Event Type  Injury  
Manufacturer Narrative

On 02/06/07, a field service engineer inspected the laser and performed a scheduled preventative maintenance. The laser system met specifications and performed as intended. The following month, an intralase clinical applications specialist (cas) provided surgery support and observed the site has been modifying their laser settings on a continuous basis, against the advice of the cas. Additionally, the site has had on-going construction adjacent to the surgical suite since 2006 that is stirring up dust and debris in the area. An environmental company evaluated the surgical site and noted that the ventilation system was not working effectively, most likely due to an air filter that was improperly installed. White powder was observed on equipment and noted in the environmental report, even though the site uses powder free gloves.

 
Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the patient presented with grade 2 diffuse lamellar keratitis (dlk) in both eyes (ou). A flap lift and rinse was performed ou on the same day. Dlk seemed to progress to grade 3-4+ in the right (od) eye and grade 3+ dlk in the left (os) eye so a second lift and rinse was performed ou three days later, and a third lift and rinse was performed ou the following day. Central cornea of od began melting on the same day. Patient was treated with oral and topical steroids and a bandage contact lens was placed after the first lift and rinse. The patient's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative uncorrected visual acuity (ucva) is 20/50 od and 20/20 os. The patient's next follow up visit is scheduled for approx one and a half month later. Additional information will be supplied to fda when received. The association between the event and the device is unknown.

 
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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
carrie garufis
9701 jeronimo road
irvine , CA 92618
9498595230
MDR Report Key835599
Report Number2032002-2007-00022
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 03/08/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2007
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 Received03/08/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2006
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: 04/05/2007 Patient Sequence Number: 1
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