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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASER SURGERY

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LASER SURGERY Back to Search Results
Event Date 12/05/2005
Event Type  Injury  
Event Description

Complications from lasik surgery in 2005. Prior to surgery in 2004, i was diagnosed with an autoimmune disease - thyroid eye disease. I was treated with radiation therapy in 2004 to control inflammation in eyes. I was told i was a candidate for surgery with worse case senario being i may have to wear glasses or contacts to get 20/20 vision. Vision deteriorated over time and i had 2 refloat procedures to try to improve the situation. I had 12 sutures placed in my left eye on the second refloat procedure, to help hold the flap in place. My vision post lasik is 20/200 in my left eye and 20/70 in my right eye. Glasses do not correct the problem and contacts are not an option because i am intolerant to them. I spent 6 months with a lens specialist at the (b) (6) with no success. Due to the lasik surgery, i suffer from vision loss, double vision, halos, irregular astigmatism, anasometropia and dry eye syndrome. I lost my job of 16 years due to the complications.

 
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Brand NameNA
Type of DeviceLASER SURGERY
MDR Report Key1621621
Report NumberMW5014955
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/25/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 02/25/2010 Patient Sequence Number: 1
Treatment
CONTACT LENS THERAPY FAILURE
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