XEN 45 GTS 5507-001

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 2020-03-25 for XEN 45 GTS 5507-001 manufactured by Allergan (irvine).

Event Text Entries

[186511990] Article citation: linton, emma and au, leon. "technique of xen implant revision surgery and the surgical outcomes: a retrospective interventional case series. " ophthalmology and therapy 9, 2020, (pages 149-157). Further information from the corresponding author regarding event, product, and patient details has been requested. No additional information is available at this time. The event of hypotonus maculopathy is a physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for the event.
Patient Sequence No: 1, Text Type: N, H10


[186511991] The article "technique of xen implant revision surgery and the surgical outcomes: a retrospective interventional case series. " noted a patient with a xen 45 gel stent suffered hypotonous maculopathy even though the iop never fell below 10 mmhg when measured. This condition self-resolved without treatment within 1 month and final visual acuity was not compromised.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011299751-2020-00149
MDR Report Key9880029
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-02-15
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-25
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 ContactMRS. MICHELLE BURGESS
Manufacturer Street12331-A RIATA TRACE PARKWAY BUILDING 3
Manufacturer CityAUSTIN TX 78727
Manufacturer CountryUS
Manufacturer Postal78727
Manufacturer Phone7372473605
Manufacturer G1ALLERGAN (IRVINE)
Manufacturer Street2525 DUPONT DRIVE
Manufacturer CityIRVINE CA 92612
Manufacturer CountryUS
Manufacturer Postal Code92612
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXEN 45 GTS
Generic NameIMPLANT, EYE VALVE
Product CodeKYF
Date Received2020-03-25
Catalog Number5507-001
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALLERGAN (IRVINE)
Manufacturer Address2525 DUPONT DRIVE IRVINE CA 92612 US 92612


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-25

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