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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 05/01/2008
Event Type  Injury  
Manufacturer Narrative

Determination of root cause: assessment: a surgery performance verification was conducted on this system from event date through the following month. The analysis determined that the laser performance factors analyzed were operating within specification during the time of this patient's surgery. Non-product factors including pt response to the laser ablation, pt healing characteristics and preoperative pt selection could not be reviewed as the surgeon declined to provide any specific pt info. His last statement regarding the patient's vision does not indicate bcva or ucva and there are no pre-operative measurements for comparison. Conclusion: based on the results of the investigation of product and non-product factors, the device was not found to be a contributor to the reported decrease in bcva. However, the non-product related factors mentioned above may have been contributor.

 
Event Description

A surgeon reports one pt with decreased bcva following lasik surgery. Follow-up with the surgeon indicates the patient's vision has returned to 20/20, the topographies look well centered, the epithelial irregularities have cleared with the use of dry eye medication and punctal plugs. The surgeon also stated the pt has not been harmed or injured. The surgeon did not provide any info regarding this patient's pre-op bcva measurement and has declined to provide any other info regarding this pt, and requested we not contact him any further regarding this matter.

 
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Brand NameLADARVISION 4000
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON-ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
suite 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 Key1082580
Report Number1061857-2008-00167
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/27/2008
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 Number8065490084
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/27/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/17/2001
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
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