MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-13 for CLARITI 1 DAY (SOMOFILCON A) manufactured by Coopervision Costa Rica Srl.
[138760962]
No root cause could be established, the relationship between the coopervision device and the adverse event is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[138760963]
The patient sought medical attention on (b)(6) 2018 after experiencing symptoms of redness and irritation in the right (od) eye for three days, the patient presented with circumlimbal redness. The patient was prescribed pred forte. The patient was seen for follow-up four days later with eye pain and decreased vision. The eye care provider notes 2+ cells and flare of the right eye and initiated antibiotic therapy. The patient was diagnosed with iridocyclitis of the right eye and was prescribed bactrim. Three days later the patient was seen for follow-up, it is reported that while symptoms were improving, cells and flare were slightly increased and accumulating. The patient was prescribed additional medications of cyclopentolate and durezol. At the three-day follow-up symptoms were gone and vision was improving. The patient was instructed to taper steroid use. As of (b)(6) 2018, the eye care provider states the incident has resolved with no permanent conditions and the patient has resumed lens use. This event is being reported due to the necessity of medical intervention and/or medication in order to prevent or preclude permanent impairment of the eye function or structure from the condition of uveitis and/or iritis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012123291-2019-00001 |
| MDR Report Key | 8418237 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2018-06-07 |
| Date Added to Maude | 2019-03-13 |
| 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 COSTA RICA SRL |
| Manufacturer Street | ZONA FRANCA EL COYOL BUILDING 23 |
| Manufacturer City | ALAJUELA, 20101 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLARITI 1 DAY (SOMOFILCON A) |
| Generic Name | CLARITI 1 DAY (SOMOFILCON A) |
| Product Code | MVN |
| Date Received | 2019-03-13 |
| Returned To Mfg | 2019-03-05 |
| Lot Number | CB037119 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERVISION COSTA RICA SRL |
| Manufacturer Address | ZONA FRANCA EL COYOL BUILDING 23 ALAJUELA, 20101 CS 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-13 |