MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-24 for CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) manufactured by Coopervision Cl Kft.
[142944876]
The relationship between the coopervision device and the event is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[142944877]
It was reported by the eye care provider that the patient experienced acute red eye, pain and soreness, irritation, and a reduction in vision each time she used the device. It is stated that the patient was hospitalized after wearing the lenses. Good faith efforts have been made to obtain additional information without success, additional information is unknown. This event is being reported in an abundance of caution due to incomplete diagnosis, allegation of hospitalization, lack of medical information, and unknown resolution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009108089-2019-00002 |
| MDR Report Key | 8545331 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 ULETI PARK, 3EP |
| Manufacturer City | GYAL, BUDAPEST 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 MULTIFOCAL (SOMOFILCON A) |
| Generic Name | CLARITI 1 DAY MULTFOCAL (SOMOFILCON A) |
| Product Code | MVN |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-03-26 |
| Lot Number | Y0062581 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERVISION CL KFT |
| Manufacturer Address | H-2360 GYAL PROLOGIA ULETI PARK, 3EP GYAL, BUDAPEST 7100 HU 7100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-04-24 |