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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC INTRALASE FS LASER LASER KERATOME

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AMO MANUFACTURING USA, LLC INTRALASE FS LASER LASER KERATOME Back to Search Results
Model Number 20002
Device Problem Normal
Event Type  Injury  
Manufacturer Narrative

A clinical development specialist (cds) has been in contact with the physician since 07/30/2008 obtaining pt f/u status. According to the physician, the root cause of the reported event was narrowed down to the gloves that were being use during surgery. Since the surgeon discontinued the use of the gloves, there have been no further cases of dlk. In 2008, a field svc engineer (fse) visited the site and performed a quarterly preventive maintenance (pm). Device performed according to specs. Additional: other, opaque bubble layer, thick flaps, sticky lifts.

 
Event Description

The intralase fs laser was used to create corneal flap(s) for lasik surgery (exact date(s) not provided). Pt's flaps were thicker than expected with opaque bubble layer (obl) at the pocket which resulted in sticky lifts. Post-operatively pts presented with diffuse lamellar keratitis (dlk). Stage of dlk varies in degree from stage 1-3 with 3 -5 pts requiring a flap lift and rinse. Pt info was requested from the user facility, however, no pt info was provided. The surgeon confirms that all cases have resolved with steroidal treatment and no loss of vision.

 
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Brand NameINTRALASE FS LASER
Type of DeviceLASER KERATOME
Manufacturer (Section D)
AMO MANUFACTURING USA, LLC
irvine CA 92618
Manufacturer (Section G)
AMO MANUFACTURING USA, LLC
9701 jeronimo road
irvine CA 92618
Manufacturer Contact
james gan
1700 st. andrew pl.
santa ana , CA 92705
7142478365
MDR Report Key1147487
Report Number2032002-2008-00004
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/05/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number20002
Device Catalogue Number20002
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/05/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2003
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: 09/02/2008 Patient Sequence Number: 1
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