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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAR 4 LASER MACHINE

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STAR 4 LASER MACHINE Back to Search Results
Event Date 06/06/2008
Event Type  Injury  
Event Description

A dr has botched my lasik procedure resulting in two difference injuries. He has also falsified my medical records via change in dates and omission of info, in order to falsify the order of events and his subsequent culpability for the injury-s-. Dr left a fold in the flap of my right eye, resulting in a vertical "crease" in my vision, and pressure in my right eye. He either did not have the proper equipment, or did not know how to use the equipment to perform a flap lift and re-set, in order to remove the fold. I suspect that he does not know how to do a flap lift/stretch and re-set, because he does not schedule one-day-after appointments for his lasik patients -he performs lasik on fridays, with follow-up the following week at approx day 4-. Dr also does not know how to properly assess flap folds, because he severely under-estimated the injury in his notes. After his apathetic, regarding my poor visual quality, and my numerous complains, he finally referred me to another facility, where my injury required a flap lift and suture at 7 weeks post-op. Immediately before my appointment, dr abruptly cancelled my appointment and "dismissed" me form his office -those are the terms his office personnel uses-, therefore, i have not seen dr since 2008. Dr carved my eyes each to see something different; which has permanently impaired my binocular vision. Ghosting exists in both eyes, with light spraying outward to the left in my left eye, and to the right in my right eye. Note that the prescription appears correct, however, the carving / curvature of my corneas is obviously wrong, resulting in extreme distortion in my vision. Corrective measures attempted: i have attempted a glasses prescription to correct this error -did not work. Another dr, is reluctant to do anything else, because i am able to read the eye chart -prescription correct, visual quality. Dr(third), is suggesting catz prk, which is currently not fda approved, and only available outside the u. S. Is there a problem with this laser. Why is it being used incorrectly? dose or amount: not known, frequency: not known, route: unk. Diagnosis or reason for use: lasik in 2008.

 
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Brand NameSTAR 4 LASER MACHINE
Type of DeviceSTAR 4 LASER MACHINE
MDR Report Key1517753
Report NumberMW5013188
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/25/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No

Patient TREATMENT DATA
Date Received: 10/25/2009 Patient Sequence Number: 1
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