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U.S. Department of Health and Human Services

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

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ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065490006
Device Problem Unknown (for use when the device problem is not known)
Event Date 06/04/2004
Event Type  No Answer Provided  
Event Description

Alcon received a voluntary medwatch from the fda. A pt reports chronic problems and disability following lasik surgery. Pt records were received and reviewed. This pt was treated for a monovision outcome, the left eye being treated for distance vision, the right for near vision. During the post-op period, the pt experienced dry eye issues, trouble with depth perception in the left eye, difficulty reading newsprint, halos at night and blurry vision. The surgeon noted early dry macular degeneration approx 5 months post-op, blepharitis throughout the later post-operative period, and noted the blepharitis and dry eye issues were affecting the pt's vision. Following an enhancement on the right eye, the pt reported an improvement to the near vision, but the mid-range was not good. The pt continued to have near vision difficulties throughout the post-op period. At the last post-op exam provided, the pt experienced a decrease in bcva in the right eye from the initial pre-operative measurement.

 
Manufacturer Narrative

A surgery database performed verification was conducted on this system. The analysis determined the laser performance factors analyzed were operating within spec during the time of this pt's initial surgery. Investigation including root cause analysis is in progress. A supplemental mdr will be filed when additional reportable info becomes available.

 
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Brand NameLADARVISION 4000
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 Key1089204
Report Number1061857-2008-00165
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
Device Catalogue Number8065490006
OTHER Device ID NumberJUPITER 5.13
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? Yes
Date Device Manufactured03/01/2001
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
Treatment
FOSAMAX 70 MG WEEKLY
LEVOTHROID .125 MG QD
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