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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 08/14/2008
Event Type  Injury  
Event Description

In 2008, i was undergoing a lasik procedure. The doctor had just started the procedure on my right eye. The first part of the procedure required the use of a microtome cutter that cuts a flap in eye tissue to expose the cornea for the laser treatment. However, in the process of using the microtome, i experienced sharp very intense pain, the doctor made a comment like - "oops", or "oh know"- he explained that "i have to stop, i cannot do laser on you just now, we must do it later-, he then said that he needed to allow me to heal and that i had to come back the next day -friday- and saturday so he can see the healing. On friday, i was seen by another dr. He looked at my eye and i asked him what happened the day before, i also told him, that during and after the procedure, dr never told me what happened and since i was sedated during that procedure i was not thinking clearly. Friday, i asked this other dr what happened. This dr. Told me that dr. Had cut or nicked my cornea. I told him my eye hurt and i could not see out of it. Dr. Said that dr. Wanted to look at my eye on sunday. I am reporting this because i am a former bio medical engineer with experience investigating pt device failures. I will be seeking medical help from insurance co. Next week, however, medical literature shows that cornea cuts, and abrasions often leave permanent eye damage, i have been in much pain for two days, i am shocked and dismayed by the unprofessional behavior of my surgical doctor, i was injured because either the device malfunctioned or the doctor made mistake during the procedure. Thus, this is a reportable event. Dose or amount - unk, frequency - unk, route, unk, diagnosis or reason for use - unk.

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Brand NameUnknown Brand Name
Type of DeviceLASIK
MDR Report Key1125904
Report NumberMW5008011
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/16/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Date Received: 08/16/2008 Patient Sequence Number: 1