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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON REFRACTIVE HORIZONS, INC. ALCON LADAR 6000

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ALCON REFRACTIVE HORIZONS, INC. ALCON LADAR 6000 Back to Search Results
Model Number LADAR 6000
Event Date 12/13/2006
Event Type  Injury  
Event Description

I had custom wavefront lasik surgery in late 2006. The treatment used an alcon ladar 6000 excimer laser system made by alcon refractive horizons. I had an adverse outcome, with under-correction and increased central curvature errors in both eyes. My doctor reported topographical irregularities to alcon, including a "significantly steeper central area". In addition to details of my specific case, the doctor also reported that the facility had experienced a substantial increase in the overall number of enhancement treatments required compared to their prior alcon ladar 4000 system. According to my doctor, alcon did not provide any info then and no further info was received from alcon until the ladar 6000 device safety alert was issued on february 21, 2007. I was given one additional enhancement treatment in the left eye in 2007 and two additional enhancement treatments in the right eye in 2007 and 2008. These procedures were successful in removing residual refractive errors but, since custom treatment was regarded as "off-label" for enhancement procedures, no attempt was made to resolve my high-order aberrations. I continued to complain of blurry vision, double images, glare and halos. More debilitating, though, were headaches i experienced in any vision-intensive activity, particularly with high detail and/or motion. Even routine activities like shopping became difficult. I continue to receive regular eval and monitoring from my doctor, but all treatment options through the local facility have been exhausted. I then decided to pursue other treatment options at other facilities, both regionally and nationally. I made numerous attempts to ask questions of alcon. Since alcon's device safety report mentioned topographically-observed central islands, but did not describe any of the island parameters, i asked alcon what range of topographic parameters they included in their use of the term "central islands". Since the device safety alert mentioned problems at other surgical centers, i asked for references to other doctors who might be doing follow-up eval and/or treatment of alcon ladar 6000 patients. Since alcon had collected considerable info from my personal medical records through contact directly with my doctor, i asked alcon to provide a summary report -without any patient's personally identifiable info-, including typical central island parameters, possible changes over time, and any additional treatments that had been tried at other facilities. The telephone number alcon had provided in the fda recall was not even the right department at alcon, so it took a number of days for alcon to decide who i should contact. Alcon's eventual response was not from any medically qualified staff person, but rather from their legal department, stating that they were unable to answer any of my questions. Alcon has also intervened and interfered with my attempt to enlist the services of another medical facility. Finally, when my doctor asked alcon many of the same questions, alcon also declined to respond to the doctor. As of 2008, alcon had not responded to even one of my questions or any of my doctor's questions. We know that alcon collected but, now that i need help from alcon to better understand the adverse impact of the ladar 6000 system, the info flow has stopped. Not only did alcon injure me through their ladar 6000 system, but now they are further adversely impacting me by continuing to withhold info that might facilitate my further treatment and recovery. Dates of use: 2006 - 2007. Diagnosis or reason for use: custom wavefront lasik.

 
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Brand NameALCON
Type of DeviceLADAR 6000
Manufacturer (Section D)
ALCON REFRACTIVE HORIZONS, INC.
2800 discovery dr.
orlando FL 32826
MDR Report Key1174023
Report NumberMW5008392
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/23/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberLADAR 6000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/21/2007
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 09/23/2008 Patient Sequence Number: 1
Treatment
CUSTOMCORNEA A WAVEFRONT LASIK
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