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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/01/2003
Event Type  Injury  
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as when additional reportable info becomes available.

 
Event Description

Alcon received a voluntary medwatch from the fda. The pt reports following lasik surgery for severe hyperopia and astigmatism, she is experiencing a loss of best corrected visual acuity (she cannot achieve 20/20 in the right eye), halos, starbursts, dry eyes, ghosting and loss of contrast sensitivity. The pt also reports she no longer drives at night because the oncoming headlights obscure the road. In addition, the pt stated she had difficulty holding her eye still during the procedure,although the dr repeatedly instructed her to hold still. The surgery was 5 yrs ago, and the pt still has symptoms. Additional info has been requested.

 
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Brand NameLADARVISION
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2800 discovery dr., 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 Key1088924
Report Number1061857-2008-00166
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/25/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/2008
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: 07/25/2008 Patient Sequence Number: 1
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