UNKNOWN NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-06-29 for UNKNOWN NA manufactured by Manufacturer Unk.

Event Text Entries

[18386816] On (b)(6) 2015, avedro received a letter from the dept of health and human services regarding a voluntary medwatch (mw5042042) submitted by a patient who was enrolled in an unidentified clinical study (study reference number and study investigator were not identified in the report) for corneal collagen cross-linking (cxl) on or about (b)(6) 2013. The patient reported that she had severe fluctuating vision due to a radial keratotomy procedure in the late 1990's. In 2013, the study investigator conducted a thermal conductive keratoplasty (tck) on the left eye (48 spots welded) one day before the cxl procedure. After the tck, the patient lost all functional vision with severe pain. The next morning, the investigator performed the cxl procedure on the patient's left eye. Immediately after the cxl procedure, the patient's vision was even more distorted, with severe dry eye and extreme pain. It is unclear whether or not the patient returned to the study site a year later for a follow-up. The patient reported that she is unable to drive and has poor quality of life due to pain and very poor vision.
Patient Sequence No: 1, Text Type: D, B5


[18441083] There are no avedro products or identifiers in mw5042042. Neither of the two medical products included in the report: an opthalmic sponge and branded equipment: "uv ultra light" are sold, distributed or used in any way by avedro. Avedro's crosslinking technology is in pre-approval status in the united states. Clinical trails with avedro's cross-linking technology were ongoing around the date of the event. Based on the patient's description of the event, and her medical history, it does not appear the patient was enrolled in any of avedro's clinical trails. Eligibility requirements of the clinical study would have precluded this patient from enrolling in the avedro studies due to the previous radial keratotomy (rk) and the tck. In addition, rk (exclusionary on its own) results in scarring to the eye that would have be notable to medical staff during the initial baseline exam - and consequently result in secondary exclusion of the subject from participation in any of avedro's clinical studies. Additionally, the study protocols do not allow another procedure, experimental or otherwise, to be performed on the study eye within 30 days of the study enrollment. Avedro evaluated serious adverse events reported in avedro's clinical studies and this patient's initials or event narrative do not match any of our reports. Based upon the avedro investigation and the information provided by the reporter, the products involved in this event were not manufactured by avedro. A follow-up report to the fda will be provided should new, contradictory information be made available.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007851054-2015-00001
MDR Report Key4902210
Report Source00
Date Received2015-06-29
Date of Report2015-06-23
Date of Event2013-06-06
Date Mfgr Received2015-06-23
Date Added to Maude2015-07-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSTEPHEN ZOLLA, VP
Manufacturer Street230 THIRD AVENUE
Manufacturer CityNORTH WALTHAM MA 02451
Manufacturer CountryUS
Manufacturer Postal02451
Manufacturer Phone7818957803
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic Name"UV ULTRA LIGHT"
Product CodeFTC
Date Received2015-06-29
Model NumberUNK
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMANUFACTURER UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-06-29

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