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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 03/20/2007
Event Type  Injury  
Event Description

The inralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively (the following day) the pt presented with stage 2 diffuse lamellar keratitis (dlk) in both eyes (ou). A flap lift and rinse was performed ou four days later. Pt was treated with topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative bcva is 20/25 od and 20/20 os. The pt responded to treatment and dlk has resolved. The association between the event and the device is unk.

 
Manufacturer Narrative

In 2007, a field service engineer inspected the laser. The laser sys met specs and performed as intended. Five days later, an intralase clinical applications specialist (cas) provided surgery support and observed mold inside the sterilizer. Cas recommended replacement with new sterilizer and site followed recommendation. Additionally, cas modified laser settings. It should be noted that the american academy of ophthalmology (aao) recommends treating stages 1 & 2 dkl with topical steroids and observation. The aao does not recommend performing a flap lift & rinse at these mild stages. The physician did not follow the recommended treatment protocol.

 
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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
carrie garufis
9701 jeronimo road
irvine , CA 92618
9498595230
MDR Report Key840155
Report Number2032002-2007-00036
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 03/21/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2007
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
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2007
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/01/2004
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: 04/19/2007 Patient Sequence Number: 1
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