MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-05-22 for IPRISM CLIP IPC05 manufactured by Glaukos Corporation.
[109010502]
The device has been received for evaluation. The investigation is in progress and findings will be provided in a supplemental report. The device history records were reviewed for this manufacturing lot and there were no non-conformities found to be related to the reported event. As part of the device history records review, the sterilization records for this lot were reviewed and this device lot passed sterility tests. A complaint history review was completed for this lot # and no similar issues have been reported. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109010503]
The customer reported that prior to patient contact, a foreign material was observed in the packaging of an unopened iprism clip. There was no patient contact as the product was not used. A back up product was opened and used for the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032546-2018-00047 |
| MDR Report Key | 7533637 |
| Report Source | OTHER |
| Date Received | 2018-05-22 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2017-12-20 |
| Date Added to Maude | 2018-05-22 |
| 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. BRITTANY MASSEY |
| Manufacturer Street | 229 AVENIDA FABRICANTE |
| Manufacturer City | SAN CLEMENTE CA 92672 |
| Manufacturer Country | US |
| Manufacturer Postal | 92672 |
| Manufacturer Phone | 949367960 |
| Manufacturer G1 | GLAUKOS CORPORATION |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IPRISM CLIP |
| Generic Name | RING, OPHTHALMIC (FLIERINGA) |
| Product Code | HNH |
| Date Received | 2018-05-22 |
| Returned To Mfg | 2018-04-27 |
| Model Number | IPC05 |
| Lot Number | 9441442 |
| ID Number | NI |
| Device Expiration Date | 2018-11-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAUKOS CORPORATION |
| Manufacturer Address | 229 AVENIDA FABRICANTE SAN CLEMENTE CA 92672 US 92672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |