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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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Device Problem Insufficient Information (3190)
Patient Problems Headache (1880); Blurred Vision (2137); Loss of Vision (2139); Halo (2227)
Event Date 06/07/2012
Event Type  Injury  
Event Description
I had lasik surgery at (b)(6), that the surgeon said was successful.When i returned the next day for follow-up, i was told everything went well.A week later at a subsequent follow-up, i complained that i could not see out of my left eye.The nurse, (b)(6), said to me that the vision was probably overcorrected, and i would need surgery again.When the doctor came in, she said there was no overcorrection; i just needed time to heal.A month later, i complained about the same problem, and was told again that i just needed to heal.I was charged (b)(6) for temporary glasses to use until my eye healed.Two months later, at the next follow-up, i said again that vision was blurry out of my left eye, but again i was told that the surgery was successful and that i just took longer to heal than normal.I was scheduled for another follow-up 6 months later.I began to experience starburst, halos, double-vision, blurred vision, and severe headaches.I made an appointment with an ophthalmologist on (b)(6) 2013, who advised that because the corrected vision was so different in each eye -1 in the right, -4.75 in the left, i would need glasses again to alleviate the symptoms and to see clearly.
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Brand Name
MDR Report Key3202328
MDR Text Key3473753
Report NumberMW5030724
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/26/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age38 YR
Patient Weight66