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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 05/26/2007
Event Type  Injury  
Manufacturer Narrative

On 05/04/2007, a field service engineer inspected the laser and performed a routine preventative maintenance. The laser system met specifications and performed as intended. Twenty seven days later, an intralase clinical applications specialist (cas) visited the site and modified the laser settings to doctor's preference. The laser met specifications and performed as intended upon departure. A root cause has not been identified for the reported event.

 
Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the pt presented with trace diffuse lamellar keratitis (dlk) on the right (od) eye and stage 2+ on the left (os) eye. A flap lift and rinse was performed the following day on the left (os) eye only. Pt was treated with oral and topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 both (ou) eyes. Postoperative bcva is 20/100 od and 20/15-2 os. The od eye was corrected for near vision and the bcva taken was distance vision (monovision treatment). The pt responded to treatment and dlk has 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 Key873551
Report Number2032002-2007-00057
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 05/29/2007
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 Received06/03/2007
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: 07/02/2007 Patient Sequence Number: 1
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