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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED MEDICAL OPTICS INTRALASE PT INTERFACE

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ADVANCED MEDICAL OPTICS INTRALASE PT INTERFACE Back to Search Results
Device Problem Suction Problem
Event Date 01/01/2009
Event Type  Injury  
Manufacturer Narrative

A clinical development specialist (cds) has been in contact with the site since the report of this event, obtaining pt status. Cds provided surgery support and performed an investigation in attempt to identify a potential root cause for the suction loss. The cds assessed the physician's surgical technique and found their practices acceptable. The site has returned the pt interface for investigation. Other, epithelial slivers.

 
Event Description

The intralase pt interface was used in conjunction with the intralase fs laser to create corneal flap(s) for lasik surgery (exact date(s) not provided). The surgeon experienced suction loss during the procedure, which lead to incomplete flap(s). The surgeon reapplied, repeated the sidecut causing epithelial slivers. Postoperatively a small section of the epithelium was removed and a bandage contact lens was placed. Pt's postoperative visual acuity (va) is 20/20 as of early 2009. The association between the event and the device is unk.

 
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Brand NameINTRALASE PT INTERFACE
Manufacturer (Section D)
ADVANCED MEDICAL OPTICS
santa ana CA 92705
Manufacturer (Section G)
ADVANCED MEDICAL OPTICS
rd. 402n
p.o. box 1408
anasco PR 00610
Manufacturer Contact
angela pineda
1700 e. st. andrew pl.
santa ana , CA 92705
7142478805
MDR Report Key1335464
Report Number2648035-2009-00018
Device Sequence Number1
Product CodeHNO
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/29/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer02/27/2009
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/29/2009
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/27/2009 Patient Sequence Number: 1
Treatment
INTRALASE FS LASER
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