MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-03 for CLARITI 1 DAY TORIC (SOMOFILCON A) manufactured by Coopervision Cl Kft.
[188359034]
No product was returned to the manufacturer for device evaluation and no lot number provided. The manufacturer is unable to investigate further at this time. Should further information become available, coopervision will submit a follow-up report. The relationship between the coopervision device and the incident is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[188359035]
It is reported that the patient experienced a severe allergic type response while using the device and sought emergency medical treatment from a hospital facility. The patient states the treating physician suspects the contact lens storage solution to be the cause of the incident. 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 unconfirmed diagnosis, lack of medical information, and unknown resolution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009108089-2020-00004 |
| MDR Report Key | 9659950 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date Mfgr Received | 2020-01-05 |
| Date Added to Maude | 2020-02-03 |
| 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 UZLETI PARK, 3 EP |
| 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 TORIC (SOMOFILCON A) |
| Generic Name | CLARITI 1 DAY TORIC (SOMOFILCON A) |
| Product Code | MVN |
| Date Received | 2020-02-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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, BUDAPEST 7100 HU 7100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-03 |