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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 08/24/2007
Event Type  Injury  
Event Description

The intralase fs laser was used to create a corneal flap for lasik surgery in 2007 on patient's left (os) eye. The doctor reported he experienced a difficult flap lift, excessive opaque bubble layer (obl) and centration difficulties as patient had loose epithelium. A bandage contact lens (bcl) was placed due to an irregular corneal surface. The patient's preoperative best corrected visual acuity (bcva) was 20/20-2 os. Patient's postoperative bcva is 20/60 os. Current bcva has been requested from the facility, but information has not been provided as of 9/21/07. If additional information becomes available, a supplemental report will be submitted. The association between the event and the device is unknown.

 
Manufacturer Narrative

An intralase field service engineer (fse) verified complete system operation, and found the laser system met specifications and performed as intended.

 
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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 Key916768
Report Number2032002-2007-00068
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 08/24/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2007
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 Received08/24/2007
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: 09/21/2007 Patient Sequence Number: 1
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