MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-03 for BIOFINITY SPHERE (COMFILCON A) manufactured by Coopervision Manufacturing, Ltd..
[188105602]
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
[188105683]
The patient states the experienced blurred vision upon instilling a new contact lens, after removing the lens, the patient experienced pain and had difficulty opening the eye and sought medical treatment. The patient was diagnosed with corneal epithelial erosion and corneal chemical burns of the right (od) eye and was prescribed sodium hyaluronate ophthalmic solution, diquas (diqualfosol sodium) ophthalmic solution, and sanbetason (betamethasone sodium phosphate) ophthalmic solution. The patient was seen for follow up visits at two and six days following the event where abrasions were still present on the eye. The patient was instructed to return for follow-up in an additional week but did not return to this clinic. At two and three weeks after the event the patient was seen by two separate eye care providers, it is unknown if the patient continued to experience symptoms, however three weeks after the initial incident the patient states they had not resumed contact lens use. This event is being reported in an abundance of caution due to lack of medical info, 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 injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614392-2020-00004 |
| MDR Report Key | 9782238 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-02 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7569874 |
| Manufacturer G1 | COOPERVISION MANUFACTURING, LTD. |
| Manufacturer Street | SOUTH POINT HAMBLE UNIT 2 |
| Manufacturer City | SOUTHAMPTOM, HAMPSHIRE SO314RF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SO31 4RF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOFINITY SPHERE (COMFILCON A) |
| Generic Name | BIOFINITY SPHERE (COMFILCON A) |
| Product Code | LPM |
| Date Received | 2020-03-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERVISION MANUFACTURING, LTD. |
| Manufacturer Address | SOUTH POINT HAMBLE UNIT 2 SOUTHAMPTOM, HAMPSHIRE SO314RF UK SO31 4RF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |