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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER LADAR VISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CENTER LADAR VISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Device Problem Unknown (for use when the device problem is not known)
Event Date 12/05/2007
Event Type  Injury  
Manufacturer Narrative

Unk if device is available for eval. No device identifier is available. Investigation including root cause analysis is in progress. A supplemental mdr will be filed when add'l reportable info becomes available.

 
Event Description

Rec'd a voluntary medwatch that was submitted by a pt. The pt is experiencing starbursts at night, severe and painful dry eye and increased floaters following custom refractive surgery.

 
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Brand NameLADAR VISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
ste. 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
suite 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1076146
Report Number1061857-2008-00120
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 05/20/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/01/2008
Date Manufacturer Received05/20/2008
Was Device Evaluated By Manufacturer? No
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: 06/19/2008 Patient Sequence Number: 1
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