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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 04/02/2007
Event Type  Injury  
Event Description

The intralase fs laser was used to create bilateral corneal flaps lasik surgery in 2007. During surgery, the flap on the left eye (os) became decentered. Postoperatively, the pt presented with mild microstriae os and the following month, intervention was performed to lift, irrigate, and smooth the flap. The pt's preoperative best corrected visual acuity (bcva) was 20/20 in both eyes. Postoperatively, the pt's bcva is 20/16 in the left eye and 20/25 in the right eye. The association between the event and the device is unk.

 
Manufacturer Narrative

On 07/2007, an intralase field service manager visited the site, provided surgery support and performed preventative maintenance. The laser system was assessed, and met all specifications and performed as intended. There were no issues observed during surgery support.

 
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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 Key885873
Report Number2032002-2007-00064
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/28/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2007
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 Received06/28/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2004
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: 07/27/2007 Patient Sequence Number: 1
Treatment
VISX
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