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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - ORLANDO TECHNOLOGY CENTER LADAR6000 SYSTEM OPHTHALMIC EXCIMER LASER SYSTEM

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ALCON - ORLANDO TECHNOLOGY CENTER LADAR6000 SYSTEM OPHTHALMIC EXCIMER LASER SYSTEM Back to Search Results
Catalog Number 8065990005
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/08/2007
Event Type  Injury  
Event Description

A surgeon reports a patient experienced 'vision quality issues' following refractive surgery on the right eye. At eight months post-op, the right eye was overcorrected by +1. 00 diopter and exhibited -. 25 diopter of induced astigmatism. The patient was diagnosed with dry eyes and medication was prescribed to alleviate symptoms. Although the patient's bcva was the same as pre-op, ucva was not as the patient had expected and the patient was not happy with the outcome. An enhancement was performed on a different laser platform. Manufacturer report #1061857-2008-00013 was submitted for this patient's postoperative period for the right eye following the enhancement procedure. This report covers the patient's postoperative period on the right eye following the initial procedure, prior to the enhancement.

 
Manufacturer Narrative

Determination of root cause: assessment: a surgery database performance verification was conducted on this system. The analysis determined the laser performance factors analyzed were operating within specification during the time of this patient's surgery. Non-product factors including patient response to the laser ablation, patient healing characteristics and preoperative patient selection were reviewed. The patient presented preoperatively with a non-contributory ocular and medical history. During the 8 month postoperative period, the patient demonstrated variable residual refractive errors and the surgeon noted dry eyes in the patient's record. Medication was prescribed. Dry eye may cause temporary and unpredictable changes in the cornea that may interfere with the ability to properly measure the refractive error. The low residual refractive error demonstrated by the patient may have been associated to the postoperative complication of dry eye and/or to individual healing characteristics. 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 patient's outcome. However, the non-product related factors mentioned above may have been contributors. This report mailed in to fda on: 07/10/2008.

 
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Brand NameLADAR6000 SYSTEM
Type of DeviceOPHTHALMIC EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
suite 500
orlando FL 32826
Manufacturer (Section G)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery drive
orlando FL 32826
Manufacturer Contact
charles dolbee
6201 discovery drive
suite 500
orlando , FL 32826
8175518317
MDR Report Key1074227
Report Number1061857-2008-00155
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/17/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065990005
OTHER Device ID Number6.4.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/17/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/25/2006
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: 07/10/2008 Patient Sequence Number: 1
Treatment
THYROID (NON SPECIFIC).
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