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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 08/22/2007
Event Type  Injury  
Manufacturer Narrative

An intralase clinical applications specialist (cas) has been in contact with the site obtaining patient follow-up status, as well as trying to identify a potential root cause for dlk. The cas visited the site in 2007 and performed an investigation. In summary, the probable root cause appears to be associated with the site not draining their sterilizer regularly. The cas advised site regarding sterilization practices and the site has since changed their statim 2000 sterilizer to a graham autoclave sterilizer. In addition, surgical instruments are now put in an ultrasonic cleaner, packaged, and then autoclaved. Dlk has resolved since noted changes were implemented.

 
Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. Postoperatively (eight days later) the patient was presented with central diffuse lamellar keratitis (dlk) in both eyes (ou). The right (od) eye with stage 2+ dlk and the left (os) with 4+ dlk and slight corneal melting. A flap lift and rinse was performed on left eye only. The patient was treated with steroids. The patient's preoperative best corrected visual acuity (bcva) was 20/20. Patient's postoperative bcva is 20/30 +0. 25+0. 25x115 os with mild haze and 20/20 od. 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 Key908570
Report Number2032002-2007-00067
Device Sequence Number1
Product CodeGEX
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/04/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2007
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 Received09/04/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2007
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: 09/07/2007 Patient Sequence Number: 1
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