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U.S. Department of Health and Human Services

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

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ALCON -ORLANDO TECHNOLOGY CENTER LADARVISION OPHTHALMIC EXCIMER LASER Back to Search Results
Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2007
Event Type  Injury  
Manufacturer Narrative

Determination of root cause: assessment; a thorough complaint investigation could not be performed for this alleged event because the event was reported to alcon via a medwatch form supplied by the fda that did not contain any prod specific info, any rptr/pt contact info, any treating facility info or any attending physician/surgeon contact info. Non-prod factors including pt response to the laser ablation, pt healing characteristics and preoperative pt selection could not be reviewed because no pt specific info (pt clinical records) were available. Conclusion: a definitive root cause could not be determined due to the lack of info provided.

 
Event Description

Rec'd a voluntary medwatch report from the fda. The rptr/pt indicated experiencing visual difficulties following bilateral custom refractive surgery for myopia. This report is for the left eye, the right eye is being reported under mfr report # 1061857-2008-00182. Following surgery, the pt reported large starbursting and halos under low light conditions; reduced low light contrast sensitivity; difficulty driving at night; corneal irregularities; central islands. High increase in floaters; and posterior vitreous detachment.

 
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Brand NameLADARVISION
Type of DeviceOPHTHALMIC EXCIMER LASER
Manufacturer (Section D)
ALCON -ORLANDO TECHNOLOGY CENTER
2501 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 Key1162143
Report Number1061857-2008-00181
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Other
Reporter Occupation Unknown
Type of Report Initial
Report Date 08/26/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/30/2008
Date Manufacturer Received08/26/2008
Was Device Evaluated By Manufacturer? Yes
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: 09/02/2008 Patient Sequence Number: 1
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