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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH AND LOMB B & L CONVENTIONAL LASER NONE

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BAUSCH AND LOMB B & L CONVENTIONAL LASER NONE Back to Search Results
Event Date 03/18/2005
Event Type  Injury  
Event Description

In 2005, dr performed lasik refractive surgery on me. In 2008, i started having problems with loss of vision. After going to five different doctors, i was finally diagnosed with corneal ectasia, caused by lasik surgery in 2009. By this time my vision was deteriorating rapidly. Not only is my vision worse, than it was when i received the surgery, but i now experience double vision, ghosting, halos, glare and chronic dry eye. A lawyer suggested i get my medical records from the initial facility. After having the records reviewed, i was told, i was not a good candidate for the surgery. The dr. Not only performed the surgery, he falsified the records to show my cornea thickness was 255 mic for both eyes. During this time 250 mic was the standard measurement of cornea thickness allowed, even though most surgeons were using 300 mic as the standard. His records show my corneas were 255 mic thick, but if you read his notes, the thickness in both eyes are clearly under the standard of 250 mic. This indicates to me, he clearly and knowingly put my vision at risk. I will be quite honest with you. My quality of life has been ruined. I no longer can drive, work, and enjoy the things i loved so much, like reading, photography, cooking and so many other things. I am a prisoner in my home and have a hard time doing simple tasks. Contact lenses have not been an option for me and i will eventually have to have a cornea transplant. As i stated, i am unable to work and have no insurance. Therefore, this has not only cause a great hardship for myself, but my family as well. Because the malpractice laws in the state protect the doctors and not the patients, i am unable to sue him at this time. It was one thing to think the dr. Had made mistake, but to find out he had put me at risk deliberately was almost more than i can take. I am hoping you can prevent him from doing this to another patient and ruining another life.

 
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Brand NameB & L CONVENTIONAL LASER
Type of DeviceNONE
Manufacturer (Section D)
BAUSCH AND LOMB
MDR Report Key1485222
Report NumberMW5012851
Device Sequence Number1
Product CodeHQF
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/23/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2009
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? Yes

Patient TREATMENT DATA
Date Received: 09/23/2009 Patient Sequence Number: 1
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