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 2020-03-18 for XEN 45 GTS 5507-001 manufactured by Allergan (irvine).
[183953136]
(b)(4). A review of the device history record has been initiated. If any deviations or non-conformances are found, a supplemental medwatch will be submitted. The reported events of anterior chamber cells, conjunctiva edema, conjunctive hyperemia, exposure and bleb wound leak 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
[183953137]
Healthcare professional reported a clinical patient experienced anterior chamber cells, conjunctiva edema, conjunctive hyperemia, superficial punctate keratitis (not device related), decrease in visual acuity (not device related), and at six month follow up, the end of the device was exposed in the right eye against the xen? 45 gts. Device was removed on the same day with alcaine. Patient was prescribed vigamox and chlorsig. All current reported events have been resolved. After explant of the xen, patient experienced mild conjunctival hyperemia, mild spk (not device related), and wound leak now closed but micropoint leaks in bleb (not device related). Bleb was remodeled. Patient has stopped vigamox and chlorsig.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00107 |
| MDR Report Key | 9848717 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-04-01 |
| Date of Event | 2019-08-29 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| Catalog Number | 5507-001 |
| Lot Number | 62318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-18 |