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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK EYE SURGERY
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LASIK EYE SURGERY Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Patient Problems Corneal Edema (1791); Dry Eye(s) (1814); Blurred Vision (2137); Loss of Vision (2139); Visual Disturbances (2140)
Event Date 03/28/2013
Event Type  Injury  
Event Description
In (b)(6) 2013, i visited (b)(6) for lasik.After undergoing topography, he confirmed that i am fit to undergo lasik procedure.So i had lasik surgery on the same day and the doctor persuaded me that the surgery was a true success.Unfortunately within a week, i started experiencing poor and blurry vision and severe dryness in my eyes.I visited my doctor again and he assured me i was fine and did not need to worry, for what i was experiencing was normal and many patients don't see results immediately.He asked me to come for a regular visit which i did, but my condition continued to deteriorate and after 3 months ((b)(6) 2013) he did an additional lasik enhancement.The next few weeks (afer the lasik enhancement) my eye sight progressively got worse.I stated experiencing double vision and loss of vision sharpness in addition to dry and poor eyes.After a couple of visits my doctor told me that i am suffering from ectasia and i have to undergo "collogen cross linkage" in order to stop further progression of ectasis and the results of this process comes after 3 to 6 months.So i had the collogen cross linkage in (b)(6) 2013 as advised by my doctor.I went for regular visits and waited for almost 5 months.I was really just hoping for a miracle but conditions just worsened.In (b)(6) 2014, i had to travel overseas with my husband, so before traveling, i sought a second option from another specialist; he told me that i am suffering from post-lasik corneal ectasia and my eyes are not healthy enough for a long travel.He met with my doctor (b)(6) ; who did my lasik, enhancement and collogen cross linkage and they decided i should undergo one more "collogen cross linkage" before travel.So, i had a second cross linkage on (b)(6) 2014 and a total of 2 lasiks, plus 2 cross linkages during that year's duration.The second cross linkage was a miracle for 2-3 weeks.I was really able to see clearly.No blurry, poor and no double vision.I was just suffering from severe dry eyes which is ok compared to the other problems, but everything started up again after 2-3 weeks.Finally i started digging online for lasik complication, post lasik problems and ectasia.At the time of the first lasik, cornea thickness of my left eye was 479um (pupil center) 468 (thinnest local) and thickness of right eye was 474um (pupil center) and 460um (thinnest local).This is below 500 um of both eyes.I believe that i was not an ideal candidate for lasik.After three months, he performed an enhancement procedure as well, and made it worse.Thickness just before enhancement of left eye was 411um (pupil center and 399um (thinnest local) and thickness of the right eye was 425um (pupil center) and 413um (thinnest local).This clearly shows that my cornea was getting thinner and he just ignored it and performed the enhancement and ruined my life completely.Today, my vision is very poor, i am not able to see clearly, suffering from double vision, really dry eyes, and cannot concentrate on anything.When i look back , i realize that i should never have gone for lasik with my thin corneas, and the surgeon never suggested that i was at any risk and should not go for surgery.Mfr reported as: (b)(4).
 
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Brand Name
LASIK EYE SURGERY
Type of Device
LASIK EYE SURGERY
MDR Report Key3872148
MDR Text Key18568840
Report NumberMW5036551
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 06/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age24 YR
Patient Weight48
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