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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN UNK LASIK UNKNOWN

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UNKNOWN UNK LASIK UNKNOWN Back to Search Results
Lot Number UNKNOWN
Event Date 03/21/2010
Event Type  Injury  
Event Description

Had lasik correction of my extreme near sightedness (b)(6) 2004, contact strength were negative 11. 0. This resulted in star bursts and halos making night time driving very difficult to do. The halos and starburst have not gone away matter of fact they are worse now. Spring 2010, i experienced posterior vitreous gel detachment in the right eye, the md stated that was directly caused by the lasik that i had done on my eyes. The floaters in my line of sight in my right eye are interfering with my life. They never go away, they constantly move about. I am an rn and find that the star burst, halos, floaters -and now double images at times- are making my job difficult. At home i rarely pick up a book, nor watch tv, nor use my computer due to the discomfort i feel, the straining i do in order to try to focus clearly, which i can't achieve. By the way, i forgot to mention the constant state of dryness of both eyes, it feels like something is in them all the time. I would never ever have done this to myself if i would have been properly informed of the potential side effects and complications post lasik, i would have happily continued to wear my contacts and glasses the rest of my life. Now i have doubts as to what is going to happen with my vision especially since one md stated that i will have retinal detachment with probably blinding in my future. I tell everyone that i hear talking about maybe getting lasik done to not do it!! it is not worth the damage that they do to a person.

 
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Brand NameUNK LASIK
Type of DeviceUNKNOWN
Manufacturer (Section D)
UNKNOWN
MDR Report Key1916554
Report NumberMW5018353
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/27/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Service Personnel
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes

Patient TREATMENT DATA
Date Received: 11/27/2010 Patient Sequence Number: 1
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