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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 20003
Device Problem Normal
Event Date 09/04/2008
Event Type  Injury  
Manufacturer Narrative

On 08/25/08, a field service engineer (fse) visited the site and performed a preventive maintenance (pm). Device performed according to specifications. At about 10 days later, a clinical development specialist (cds) was in contact with the physician obtaining patient follow up status, and trying to determine a probable root cause of the obl, sticky lifts and dlk. The cds reviewed the current laser settings and determined that the energies were not likely the cause of the inflammation (dlk). However, suggested that the energies could be adjusted to address the obl and sticky lifts. The probable root cause for the dlk was not identified.

 
Event Description

The intralase fs laser was used to create a corneal flap for lasik surgery in 2008. During the procedure, opaque bubble layer (obl) occurred in the superior region near the hinge, which resulted in a sticky lift. One day post-operatively in thenext day, the patient presented with stage 2-3 diffuse lamellar keratitis (dlk). A flap lift and rinse was performed. Patient was treated with topical and oral steroids. Post-operatively the patient's uncorrected visual acuity (ucva) was 20/20+2. The patient responded to treatment and dlk has resolved. The association between the event and the device is unknown.

 
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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
angela pineda
1700 e. st. andrew place
santa ana , CA 92705
7142478805
MDR Report Key1229645
Report Number3006695864-2008-00026
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 09/04/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2008
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 Received09/04/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2007
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: 11/11/2008 Patient Sequence Number: 1
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