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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASER LASIK

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LASER LASIK Back to Search Results
Event Date 07/02/1999
Event Type  Injury  
Event Description

Lasik surgery in both eyes to correct vision of -7. 0/-7. 5. Results : severe dry eye, pain and infection that would not clear. Required 3 rounds of antibiotic eye drops. Correction regressed 1. 5 diopters in both eyes by 3 months. Left eye retreated for a "monovision" correction. This cleared up the stubborn infection suspicion that the original surgery in left eye -with a torn flap, abrasion- had somehow caused bacteria to enter eye or another foreign object was left under the flap- no more infections. Ten more years of headaches, dry eye, increased allergic conjunctivitis, vision correction fluctuations and correction regression toward increased myopia. The "monovision" correction prompted headaches ad fusion problems. Since glasses have been required for vision since 3 months after the surgery, the fusion problem is corrected with glasses. However, since the correction fluctuates and regresses, new glasses were required every few months in the first 5 years. Currently, i switch back and forth between glasses prescription approx. 4 times a year. I have not had a consistent correction in 10 years.

 
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Type of DeviceLASER LASIK
MDR Report Key1513519
Report NumberMW5013081
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/17/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2009
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

Patient TREATMENT DATA
Date Received: 10/17/2009 Patient Sequence Number: 1
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