MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-10-17 for CLARITI 1 DAY SPHERE (SOMOFILCON A) manufactured by Coopervision Cl Kft.
| Report Number | 3009108089-2019-00012 |
| MDR Report Key | 9200604 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-10-17 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-09-10 |
| Date Mfgr Received | 2019-09-16 |
| Date Added to Maude | 2019-10-17 |
| 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 | MS. MELISSA TORPEY |
| Manufacturer Street | 5870 STONERIDGE DRIVE SUITE 1 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 5857569874 |
| Manufacturer G1 | COOPERVISION CL KFT |
| Manufacturer Street | H-2360 GYAL PROLOGIA UZLETI PARK, 3 EP |
| Manufacturer City | GYAL, 7100 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 7100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLARITI 1 DAY SPHERE (SOMOFILCON A) |
| Generic Name | CLARITI 1 DAY SPHERE (SOMOFILCON A) |
| Product Code | MVN |
| Date Received | 2019-10-17 |
| Returned To Mfg | 2019-09-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERVISION CL KFT |
| Manufacturer Address | H-2360 GYAL PROLOGIA UZLETI PARK, 3 EP GYAL, 7100 HU 7100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-17 |