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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON REFRACTIVE HORIZONS, INC SUMMIT APEX PLUS EXCIMER LASER & LADARVISION (ALCON) NONE

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ALCON REFRACTIVE HORIZONS, INC SUMMIT APEX PLUS EXCIMER LASER & LADARVISION (ALCON) NONE Back to Search Results
Event Date 10/07/1999
Event Type  Injury  
Event Description

I am in receipt of your letter dated july 24, 2008 acknowledging receipt of the medical device report i recently submitted. Soon after its submission, i realized that i had made an error and that i had also omitted info that i believe may be beneficial. Therefore, i would like to take this opportunity to provide this info as well as correct the error. Relative to the error, i submitted two different results for the wavefront dated 04/02/2004 for os, not two results dated 04/02/2004 for od as stated in my report. Secondly, the report instructed the rptr not to identify the pt, physician or institution by name and i honored that request. However, due to the circumstances, i believe the fda should be aware that all my surgeries, a total of six, were performed at the facility by a peer-reviewed refractive surgeon who had and/or has a vested interest in the mfr of the lasers that were utilized in my surgeries, i. E. , receives funds for consulting, research and travel. I presume the surgeon and/or facility was obligated to file an adverse event report, and if so, our reports can be cross-referenced. Unfortunately, i am unable to ascertain as to whether adverse event reports were submitted by the surgeon and/or the facility.

 
Event Description

Initial, bilateral, lasik surgery w/summit apex plus excimer laser for moderate myopia both eyes w/mild astigmatism right eye. Within 4 months, vision was 20/200 bilaterally and blurry vision, halos, starbursts and dry eyes experienced. In 2000, bilateral surgery performed utilizing ladarvision to correct residual myopia and astigmatism. At about 8 months later, surgery performed on right eye utilizing ladarvision to correct residual myopia and regression. In 2001, surgery performed on left eye utilizing ladarvision to correct residual myopia and astigmatism. The surgery(ies) resulted in decentered ablations, irregular astigmatism, dry eyes, blurred vision, halos, starbursts, loss of contrast and has made a negative impact physically, psychologically & financially. (see scanned pages).

 
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Brand NameSUMMIT APEX PLUS EXCIMER LASER & LADARVISION (ALCON)
Type of DeviceNONE
Manufacturer (Section D)
ALCON REFRACTIVE HORIZONS, INC
2800 discovery dr
orlando FL 32826 371
MDR Report Key1068318
Report NumberMW5007494
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/30/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/02/2008 Patient Sequence Number: 1
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