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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 07/02/2007
Event Type  Injury  
Manufacturer Narrative

An intralase clinical applications specialist (cas) provided surgery support in 2007, and has been in contact with the physician obtaining patient follow-up status, as well as trying to identify a potential root cause for dlk. The cas and physician believe that the cause of dlk is due to something in the surgical suite environment. The site has recently changed their air filter, started using a disposable canulas, and changed their cleaning solution for the instruments. After implementing these changes, the hospital has noticed a significant improvement in patient outcomes. An intralase field service engineer (fse) performed preventive maintenance on july 25, 2007 and the laser system met specifications and performed as intended.

 
Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively (the next day) the patient presented with diffuse lamellar keratosis (dlk) and central striae. The following month, the patient was diagnosed with central toxic keratopathy (ctk), slight central corneal melting on the left (os) eye and doctor opted to perform a flap lift and rinse on both (ou) eyes. The patient was prescribed with topical steroids and has responded to treatment. The patient's preoperative best corrected visual acuity (bcva) want 20/20 ou. Patient's postoperative bcva is 20/20 od and 20/25+2 os. Dlk and ctk have resolved. 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
mary carvajal
9701 jeronimo road
irvine , CA 92618
9498595230
MDR Report Key907878
Report Number2032002-2007-00066
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 07/17/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/06/2007
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 Received08/09/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2007
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: 09/06/2007 Patient Sequence Number: 1
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