MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-06 for CLARITI 1 DAY SPHERE (SOMOFILCON A) manufactured by Coopervision Cl Kft.
[188993502]
To date, no lenses have been returned to the manufacturer for analysis. A lot number for the device has been supplied, the manufacturers investigation is ongoing. Lot history, device history, sterilization records and trend reporting will be reviewed. A follow-up reported will be submitted upon completion. As no supporting medical information has been received from the patient and/or her treating facility(s), the relationship between the coopervision device and the event is unconfirmed. This event is being reported in abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[188993503]
The patient alleges that she has experienced an allergic reaction in the left (os) eye after using the device. The patient reports that she has had a history of allergic response while using this product and sought medical treatment where she was prescribed antibiotic and steroid drops as well as an oral antibiotic (prednisone), additionally the patient was prescribed singulair and recommended over the counter benadryl. The patients states that on one occasion, the reaction resulted in decreased vision for approximately three days, the patient did not seek medical attention for this incident, she used the prescribed steroids and over the counter antihistamine to reduce symptoms. The patient indicates that while the medications have helped reduce symptoms, they return with the use of the contact lenses. The patient states that she was diagnosed with an allergy to the chemical benzophenone, which a component of the uv blocker in the device the patient was using. 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 lack of medical information, incomplete diagnosis, and unknown resolution. Additionally, it is unclear if the medications prescribed were used in order to prevent or preclude permanent injury or illness related to the alleged allergy or allergic response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009108089-2020-00002 |
| MDR Report Key | 9549613 |
| Report Source | CONSUMER |
| Date Received | 2020-01-06 |
| Date of Report | 2020-02-03 |
| Date Mfgr Received | 2019-12-05 |
| Date Added to Maude | 2020-01-06 |
| 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 | 2020-01-06 |
| Lot Number | Y0067008 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-06 |