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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LADAR LASER NONE

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ALCON LADAR LASER NONE Back to Search Results
Event Date 02/01/2003
Event Type  Injury  
Event Description

In 2003, i underwent lasik surgery using the ladar laser for severe hyperopia and astigmatism at the eye center. I was told i would at least be seeing 20/40 the next day, which was not the case. After going through several pairs of glasses and several months, my vision finally settled. I cannot, however, achieve 20/20 in my right eye anymore with glasses. I can't wear contacts because my eyes are too dry now, and i can't tolerate the hard lenses. I have had problems with halos and starbursts since surgery, and they continue now, 5 years later. I now also have a problem with some mild ghosting in my left eye with certain lights. I also lost contrast sensitivity as a result of the procedure. I do not drive at night unless necessary because the oncoming headlights obscure the road. I did not read and sign a consent form until after they had taken my glasses and given me ativan to calm me for the procedure. During the procedure, dr had a problem while using the laser on one of my eyes because i could not hold my eye still, apparently, and he kept telling me over and over to hold my eye still. Not so easy when he's yelling and i'm nervous as hell as a laser is burning off part of my eyeball. I just want others to know and understand the risks associated with lasik surgery and for these money-hungry doctors to be more open about the risks of this elective surgery.

 
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Brand NameALCON LADAR LASER
Type of DeviceNONE
MDR Report Key1053909
Report NumberMW5007079
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 05/28/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 05/28/2008 Patient Sequence Number: 1
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