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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 05/24/2007
Event Type  Injury  
Manufacturer Narrative

In 2007, an intralase clinical application specialist (cas) visited the site and performed an investigation in attempt to determine a root cause. Cas inquired into instrument and surgical preparation practices, as well as technique. The cas did not identify any unusual practices, and found the laser system met specifications and performed as intended. One day later, an intralase field service engineer (fse) visited the site, performed minor alignment of the oscillator and found the laser system met specifications and performed as intended. A root cause has not been identified for the reported event.

 
Event Description

The intralase fs laser was used to create corneal bilateral flaps for lasik surgery in 2007. One week postoperatively, the pt presented with central toxic keratopathy (ctk), and stria at which time the doctor opted to perform stria removal and repositioned the flap. The pt's preoperative best corrected visual acuity (bcva) was 20/20 in the right (od) eye and 20/20 in the left (os) eye. The pt's current postoperative bcva is 20/30 od, 20/30 os and 20/25 in both (ou) eyes. 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 Key873539
Report Number2032002-2007-00058
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 05/30/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2007
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 Received06/04/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2007
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: 07/02/2007 Patient Sequence Number: 1
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