ARGUS II RETINAL PROSTHESIS 011014-003-K 011014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-01-19 for ARGUS II RETINAL PROSTHESIS 011014-003-K 011014 manufactured by Second Sight Medical Products, Inc..

Event Text Entries

[65344298] All pertinent information available to second sight medical products, inc. Has been submitted. The company is submitting this mdr to ensure full compliance with 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10


[65344299] This patient was implanted with the argus ii device on (b)(6) 2015. On (b)(6) 2016, the patient came in for a routine medical check and was diagnosed with hypotony and choroidal detachment in the implanted eye. On (b)(6) 2016, the patient underwent revision surgery during which the subretinal fluid was partially drained, and the bovine patch was replaced by a human pericardium patch. On (b)(6) 2016, the patient's intraocular pressure was normal and the choroidal detachment was not present. On (b)(6) 2016, the surgeon reported that the patient's eye was stable. There was no defect or malfunction of the device associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004081696-2017-00002
MDR Report Key6265487
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-01-19
Date of Report2016-12-20
Date of Event2016-11-28
Date Mfgr Received2016-12-20
Device Manufacturer Date2014-12-21
Date Added to Maude2017-01-19
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. MARK LOAR
Manufacturer Street12744 SAN FERNANDO RD. SUITE 400
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal91342
Manufacturer Phone8188335049
Manufacturer G1SECOND SIGHT MEDICAL PRODUCTS, INC.
Manufacturer Street12744 SAN FERNANDO RD. SUITE 400
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal Code91342
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARGUS II RETINAL PROSTHESIS
Generic NameRETINAL PROSTHESIS
Product CodeNBF
Date Received2017-01-19
Model Number011014-003-K
Catalog Number011014
Lot NumberN/A
Device Expiration Date2016-12-21
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSECOND SIGHT MEDICAL PRODUCTS, INC.
Manufacturer Address12744 SAN FERNANDO RD. SUITE 400 SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-01-19

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