MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for RAYONE ASPHERIC RAO600C manufactured by Rayner Intraocular Lenses Limited.
| Report Number | 3012304651-2020-00011 |
| MDR Report Key | 9889063 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS JODIE NEAL |
| Manufacturer Street | THE RIDLEY INNOVATION CENTRE 10 DOMINION WAY |
| Manufacturer City | WORTHING, WEST SUSSEX BN148AQ |
| Manufacturer Country | UK |
| Manufacturer Postal | BN14 8AQ |
| Manufacturer G1 | RAYNER INTRAOCULAR LENSES LIMITED |
| Manufacturer Street | THE RIDLEY INNOVATION CENTRE 10 DOMINION WAY |
| Manufacturer City | WORTHING, WEST SUSSEX BN148AQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BN14 8AQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAYONE ASPHERIC |
| Generic Name | RAYONE ASPHERIC |
| Product Code | HQL |
| Date Received | 2020-03-27 |
| Model Number | RAO600C |
| Catalog Number | RAO600C |
| Lot Number | NOT AVAILABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAYNER INTRAOCULAR LENSES LIMITED |
| Manufacturer Address | THE RIDLEY INNOVATION CENTRE 10 DOMINION WAY WORTHING, WEST SUSSEX BN148AQ UK BN14 8AQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |