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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 8065490006
Device Problem Unknown (for use when the device problem is not known)
Event Date 05/18/2007
Event Type  Injury  
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when add'l reportable info becomes available.

 
Event Description

A pt reports following lasik surgery, he is experiencing floaters, glare, halos, severe starbursts and dry eyes. The pt stated the floaters make it, 'difficult to see' and he is having trouble driving due to the starbursts. The pt was seen by several drs for second opinions. One dr mentioned corneal imperfections and flat corneas. The pt indicated he had done some research and found out about central islands and thinks that is what the corneal irregularities are. This report is for the right eye, the left eye is being submitted under mfr # 1061857-2008-00082. The surgeon who performed the lasik procedure on this pt indicated, the pt did not have central islands and has not been harmed or injured by this event. The surgeon declined to provide any pt records. Pt records were provided by one of the drs the pt saw for a second opinion. The records indicate at 4 mos post-op bcva in the right eye was 20/15; left eye was 20/15-2. Ucva in both eyes was 20/20. Pt has peripheral vascular disease.

 
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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)
ALCON - ORLANDO TECHNOLOGY CENTER
2501 discovery dr.
ste. 500
orlando FL 32826
Manufacturer Contact
charles dolbee
62001 south freeway
ste. 500
fort worth , TX 76134-2099
8175518317
MDR Report Key1053754
Report Number1061857-2008-00081
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/14/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8065490006
OTHER Device ID Number5.5.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Date Manufacturer Received04/29/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/05/2000
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: 05/29/2008 Patient Sequence Number: 1
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