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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCE MEDICAL OPTICS VISX STAR S4 IR EXCIMER LASER

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ADVANCE MEDICAL OPTICS VISX STAR S4 IR EXCIMER LASER Back to Search Results
Model Number STAR S4 IR
Event Date 06/16/2008
Event Type  Injury  
Event Description

A pt underwent lasik surgery in 2008. Dr reported that the pt's right (od) eye had a irregular ablation which resulted in poor visual acuity. The pt's preoperative best corrected visual acuity (bcva) was 20/20 od. Pt's postoperative bcva is 20/100 od as of 4 days post procedure. The association between the event and the device is unk.

 
Manufacturer Narrative

Customer did not request svc. Method: medical monitor reviewed this treatment and the most likely explanation for this irregular ablation profile is poor pt fixation. Conclusion: prod was not evaluated.

 
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Brand NameVISX STAR S4 IR EXCIMER LASER
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
ADVANCE MEDICAL OPTICS
milpitas CA
Manufacturer (Section G)
AMO MANUFACTURING USA LLC
510 cottonwood drive
milpitas CA 95035
Manufacturer Contact
james gan
1700 e. st. andrew pl
santa ana , CA 92705
7142478365
MDR Report Key1125705
Report Number3006695864-2008-00011
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 07/02/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR S4 IR
Device Catalogue Number0030-1479
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/21/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/2007
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: 08/18/2008 Patient Sequence Number: 1
Treatment
PT INTERFACE
FEMTOSECOND LASER
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