UV ULTRA LIGHT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-07 for UV ULTRA LIGHT manufactured by Avedro.

Event Text Entries

[21065561] I was put in the (b)(6) study in (b)(6) 2013, due to severe fluctuating vision. I had radial keratotomy in the late 90's. (b)(6) 2013, the dr added tck surgery, the day before corneal collagen cross-linking. He welded 48 spots in my left eye. I lost all functional vision right after with severe pain. The cxl was the following morning. Immediately after my vision was even more distorted. Double and triple vision, looking thru crinkled saran wrap. Severe dry eye and extreme pain. The tck was to close the cuts made by rk. When i returned home a week later, my local doctor said my eye was literally splayed open. I cannot drive, or do the things i used to. One year later, the doctor, that did the fda study blamed the failure of the study on my noncompliance with dry eye. And he could do nothing else. He literally dumped me and my study. I have not heard from him since. And my eye in now useless. And i have no where to turn. I can't find why he did the tck, as my eye was fluctuating severely, and it is not a candidate for that procedure. I have lost my quality of life due to pain and very poor vision. What records i did finally receive, was not actual or factual. My study failed and he threw it out. My last visit, the girl doing the refractions was new and kept saying the equipment was not working.
Patient Sequence No: 0, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5042042
MDR Report Key4683978
Date Received2015-04-07
Date of Report2015-04-07
Date of Event2013-06-06
Date Added to Maude2015-04-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUV ULTRA LIGHT
Generic NameUV LIGHT
Product CodeFTC
Date Received2015-04-07
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAVEDRO


Patients

Patient NumberTreatmentOutcomeDate
00 2015-04-07

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