MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-16 for CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) manufactured by Coopervision Cl Kft.
[142236355]
Lot history, device history, sterilization records and trend reporting were reviewed, including dry manufacturing and wet manufacturing process. Manufacturer's investigation (b)(4) was raised to further investigate the incident. It was found that there was a temperature issue during the curing process which can lead to incorrect base curve measurements. However, during quality inspection and physical testing of the manufactured lot, no issues were identified. The defect identified, incorrect base curve, is considered minor with a severity rating of 2 out of 5 as there is a minor risk to ocular health of the user or minor effect on device function which may cause the user dissatisfaction but not normally result in an injury or illness. There were (b)(4) lenses manufactured from this lot and no additional complaints have been received. With three lenses being identified as out of tolerance, the incident is occurring at (b)(4) which is considered low ((b)(4)) and given a probability of failure ranking of 2 out of 5. Based on the manufacturers risk assessment and capa trigger matrix no further action is required. Coopervision does not plan to take any formal remedial corrective or preventative action, including field safety corrective action. Should additional information become available that requires corrective or preventative action, including any necessary field safety corrective action, coopervision will inform fda via a follow-up report. As the used lenses directly involved in the incident were not returned to the manufacturer, it is unclear if the lenses involved were subject to a device manufacturing deficiency, failure, or malfunction.
Patient Sequence No: 1, Text Type: N, H10
[142236356]
It was initially reported that the patient was experiencing an allergic type reaction with symptoms of eye pain, itching, and tearing since (b)(6) 2018. The patient saw a pharmacist and was given optrex (sodium hyaluronate) eye drops. The patient sought medical assistance three days later at specsavers and was instructed to continue use with the drops. On 19 november the patient saw a specialist as the condition had not improved. Examination revealed moderate punctate staining of both corneas, mild corneal infiltrates, grade three epithelial edema, and severe limbal and bulbar injection and tarsal papillae. The treating physician indicates significant papillary conjunctivitis and limbitis as well as conjunctiva injection and punctate keratopathy. The patient was prescribed dexamethasone 1% and instructed to discontinue contact lens wear for two weeks. The patient resumed lens use but experienced similar symptoms. The treating physician recommended one more week of steroid use via email. On (b)(6) 2018 the patient wore a pair of old contact lenses which were single vision, not the prescribed multifocal, and experienced no reaction. When returning to the use of the multifocal lenses, the patient continues to experience a similar reaction. The incident has since resolved, the patient has been prescribed a different daily disposable product, brand or manufacturer unknown, and is continuing lens use without incident. They physician indicates that the patient's condition in (b)(6) 2018 necessitated the use of medical intervention and medication to prevent or preclude permanent impairment of eye function or structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009108089-2019-00001 |
| MDR Report Key | 8519404 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-04-16 |
| 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 MULTIFOCAL (SOMOFILCON A) |
| Product Code | MVN |
| Date Received | 2019-04-16 |
| Returned To Mfg | 2019-02-01 |
| Lot Number | S0082997 |
| 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. Other; 2. Required No Informationntervention | 2019-04-16 |