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).
[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
| Report Number | 3011299751-2020-00149 |
| MDR Report Key | 9880029 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-15 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE BURGESS |
| Manufacturer Street | 12331-A RIATA TRACE PARKWAY BUILDING 3 |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 7372473605 |
| Manufacturer G1 | ALLERGAN (IRVINE) |
| Manufacturer Street | 2525 DUPONT DRIVE |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XEN 45 GTS |
| Generic Name | IMPLANT, EYE VALVE |
| Product Code | KYF |
| Date Received | 2020-03-25 |
| Catalog Number | 5507-001 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN (IRVINE) |
| Manufacturer Address | 2525 DUPONT DRIVE IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |