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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 8065490084
Device Problem Unknown (for use when the device problem is not known)
Event Date 02/07/2008
Event Type  Injury  
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary when additional reportable info becomes available. This report mailed in to fda on: 06/13/2008.

 
Event Description

A system operator reports a pt was overcorrected following lasik refractive surgery on both eyes. This report is for the left eye, the right eye is being reported under mfr report #1061857-2008-00104. Patient records were rec'd and indicated the left eye was under corrected by -1. 00 diopter at 2 months post-op. This eye also experienced a 1 line decrease in bcva, however, the records also indicate ucva in the left improved from 20/cf to 20/40- additional info has been requested.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr
ste 500
orlando FL 32826
Manufacturer (Section G)
ORLANDO TECHNOLOGY CENTER
2501 discovery dr
ste 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1061309
Report Number1061857-2008-00105
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/15/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/13/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065490084
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/15/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/11/2002
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: 06/13/2008 Patient Sequence Number: 1
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