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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 8065490275
Device Problem Unknown (for use when the device problem is not known)
Event Date 09/28/2006
Event Type  Injury  
Event Description

A system operator reported the laser stopped firing 67% into a procedure due to low energy. The site was advised to perform a gas change and recalibrate the system which was unsuccessful. The procedure could not be completed at that time. Pt records were provided and indicate at approximately 6 weeks post-op, the pt's right eye was undercorreted by -1. 25 diopter and there was a 1 line decrease in bcva. No further info was provided.

 
Manufacturer Narrative

Reporting of this complaint is based on receipt of a letter from fda dated april 10, 2008 regarding the fileability of complaint determined to be an injury and another complaint determined to be a reportable malfunction per the 2-year rule. As a result of this fda letter, all complaint files for the ladarvision and ladar6000 products were reviewed. Based on the criteria for filing set forth in this letter, alcon established a new 2-year reporting rule for this type of event, starting 7/10/2006. This mdr filing is a result of that retrospective review. Determination of root cause: assessment: the field service engineer (fse) was dispatched to the facility to evaluate the system. The fse confirmed the laser stopped firing after the laser warmed up. The thyratron was replaced and a system verification was performed. The returned part was tested and the thyratron was found to cause low energy. The reported issue was confirmed, but could not be duplicated in testing. Conclusion: based on the results of the investigation, the root cause of the reported difficulty was related to the thyratron.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON-ORLANDO TECHNOLOGY CENTER
2501 discovery drive ste. 500
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 south freeway
fort worth , TX 76134-2099
8175518317
MDR Report Key1047292
Report Number1061857-2008-00059
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/28/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065490275
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/23/2006
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/28/2006
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/30/2000
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: 05/16/2008 Patient Sequence Number: 1
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