MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-27 for XEN 45 GTS 5513-001 manufactured by Allergan (irvine).
[186525562]
Concomitant medical products: rhopressa and refresh. Further information from the reporter regarding event, product, or patient details has been requested. No additional information is available at this time. The events of vision abnormalities and hyperemia are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.
Patient Sequence No: 1, Text Type: N, H10
[186525563]
Patient reported they had a xen 45 gel stent implanted in the left eye. The first 5 weeks the xen gel stent looked perfect without any complication. In week 7 the patient went for a checkup and the hcp stated that the xen gel stent looked corroded and attempted to remove it but the corroded piece broke off and only a portion of the xen gel stent was able to be removed. Post removal attempt, their left eye became bloodshot red. Patient was prescribed unknown eye drops as treatment and the redness of the left eye resolved. The patient stated that the xen gel stent is located underneath lining where it is supposed to be and believes "it is still doing its job". And no further attempts to remove it will be performed. Patient also noted that their vision sometimes "gets blurry".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00158 |
| MDR Report Key | 9892228 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2020-03-27 |
| Catalog Number | 5513-001 |
| 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. Other; 2. Required No Informationntervention | 2020-03-27 |