YC-1800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for YC-1800 manufactured by Nidek Co. Ltd.

Event Text Entries

[105520108] The ophthalmologist observed pitting on the posterior surface of the lens while performing surgery. However, the ophthalmologist completed the surgical procedure by performing certain modifications to achieve the intended results. Nidek inc. Has learned that dr. (b)(6) has doubts the effectiveness/reliability of the device in question and therefore, nidek has decided to replace it with a new yc-1800. The device is not yet evaluated by nidek inc. A follow-up report to this mdr will be submitted upon the completion of device evaluation.
Patient Sequence No: 1, Text Type: N, H10


[105520109] On (b)(6) 2018, the customer contacted nidek inc. Field service manager who later communicated to nidek inc. Customer service manager to report that the doctor observed pitting lens during surgical procedure. A total of 3 incidents were reported and a separate mdr will be submitted for each case. Two patients have acrysoft sn60wf monofocal lens and one have multifocal lens. There was no serious adverse event reported from the user facility but nidek inc. Considers pitting lens issue on yc-1800 a reportable event as it is an undesirable condition and has a potential to cause or contribute to a serious injury if the issue were to recur.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936921-2018-00004
MDR Report Key7419968
Date Received2018-04-10
Date of Report2018-04-09
Date of Event2018-03-13
Date Mfgr Received2018-03-13
Device Manufacturer Date2017-08-02
Date Added to Maude2018-04-10
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 FDA3
Event Location3
Manufacturer ContactMR. TOSHIO MURATA
Manufacturer Street47651 WESTINGHOUSE DRIVE
Manufacturer CityFREMONT CA 945397474
Manufacturer CountryUS
Manufacturer Postal945397474
Manufacturer Phone5103537718
Manufacturer G1NIDEK CO. LTD
Manufacturer Street34-14 HIROSHI
Manufacturer CityGAMAGORI, AICHI 443-0038
Manufacturer CountryJA
Manufacturer Postal Code443-0038
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameYC-1800
Generic NameYAG LASER
Product CodeLXS
Date Received2018-04-10
Model NumberYC-1800
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNIDEK CO. LTD
Manufacturer Address34-14 HIROSHI GAMAGORI, AICHI 443-0038 JA 443-0038


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Deathisabilit 2018-04-10

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