MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-11 for MILOOP LENS FRAGMENTATION DEVICE FG-11881 manufactured by Carl Zeiss Meditec Cataract Technology, Inc..
| Report Number | 3012123033-2019-00007 |
| MDR Report Key | 8996817 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-11 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2019-09-30 |
| Device Manufacturer Date | 2019-03-19 |
| Date Added to Maude | 2019-09-11 |
| 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 | ED CONLEY |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO NV 89521 |
| Manufacturer Country | US |
| Manufacturer Postal | 89521 |
| Manufacturer Phone | 7753797261 |
| Manufacturer G1 | CARL ZEISS MEDITECH CATARACT TECHNOLOGY, INC. |
| Manufacturer Street | 8748 TECHNOLOGY WAY |
| Manufacturer City | RENO NV 89521 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 89521 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MILOOP LENS FRAGMENTATION DEVICE |
| Generic Name | OPHTHALMIC HOOK |
| Product Code | HNQ |
| Date Received | 2019-09-11 |
| Returned To Mfg | 2019-08-19 |
| Model Number | FG-11881 |
| Lot Number | FG19031910 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. |
| Manufacturer Address | 8748 TECHNOLOGY WAY RENO NV 89521 US 89521 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-11 |