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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTRA LASE CORP. INTRALASE FS LASER LASER KERATOME

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INTRA LASE CORP. INTRALASE FS LASER LASER KERATOME Back to Search Results
Model Number 20003
Device Problem Normal
Event Date 10/19/2007
Event Type  Injury  
Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One week post-op (approximately a week later), patient was noted to have elevated intraocular pressure (iop) in the right (od) eye due to pigmentary glaucoma. The patient's preoperative best corrected visual acuity (bcva) was 20/15 od. Postoperatively, the patient's bcva is 20/40 od. Patient treated with medications to address the increased iop. Updated patient status was requested, but information has not been provided to filutowski eye institute by co-managed office as of approx two months later. However, if additional information becomes available, supplemental report will be submitted to fda. The association between the event and the device is unknown.

 
Manufacturer Narrative

Review of the history of service provided by intralase field service engineer (fse) noted an fse visited the site on 11/12/2007 and found the laser met specifications and performed as intended. On 12/18/2007, an intralase clinical application specialist (cas) visited the site as follow up to the reported event and to obtain any new patient status information. While on site, cas check the performance of the laser and found it to meet specifications and operated as intended.

 
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Brand NameINTRALASE FS LASER
Type of DeviceLASER KERATOME
Manufacturer (Section D)
INTRA LASE CORP.
9701 jeronimo road
irvine CA 92618
Manufacturer Contact
mary carvajal
9701 jeronimo road
irvine , CA 92618
9498595230
MDR Report Key966623
Report Number2032002-2007-00072
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 11/19/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2007
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 Received11/19/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2006
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: 12/19/2007 Patient Sequence Number: 1
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