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 2020-03-25 for XEN 45 GTS 5513-001 manufactured by Allergan (irvine).
[188648253]
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 loss is a physiological complication 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
[188648254]
Patient reported they had a xen 45 gel stent implanted in their right eye and reported they experienced a terrible reaction. Patient stated they experienced swelling, inflammation, and he is unable to function normally due to the right eye. Patient stated the eye "stings, burns, and oozes" and his "eye lids puff up, lower lid greater than upper lid" the patient's doctor treated the inflammation for two weeks with ophthalmic corticosteroids and their eye improved. After discontinuation of the eye gtts, the irritation worsened. Per the consumer, their doctor does not know why the consumer is having problems with his right eye. Further information was received noting they are "still suffering with occasional pain and burning sensation, crusting on the lower eyelid, thick seepage nearly every day and some visual loss. Patient noted device remains implanted and stated "my surgeon just shrugs his shoulders and claims "everything looks fine. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011299751-2020-00141 |
| MDR Report Key | 9879338 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-27 |
| 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 | 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 | 2020-03-25 |
| 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. Required No Informationntervention | 2020-03-25 |