MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for BIOFINITY MULTIFOCAL (COMFILCON A) manufactured by Coopervision Manufacturing, Ltd..
[186583426]
No issues or non-conformances were found, no root cause could be identified with the returned sample evaluation or manufacturing history review. The relationship between the coopervision device and the event is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[186583427]
The manufacturer became aware of the event through a product return. Contact lenses were purchased by the patient from yellow zebra optical. It is reported that patient experienced pain, discomfort, and foreign body sensation ("poking feeling") in the eye after using the contact lens for half a day. The next day the patient had dried discharge, redness and pain in the. The patient sought medical treatment and was diagnosed with a corneal ulcer. Good faith efforts were made by the manufacturer obtain additional details without success; further 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 | 9614392-2020-00006 |
| MDR Report Key | 9842383 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-02-16 |
| Date Added to Maude | 2020-03-17 |
| 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 MULTIFOCAL (COMFILCON A) |
| Generic Name | BIOFINITY MULTIFOCAL (COMFILCON A) |
| Product Code | LPM |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-01 |
| Lot Number | 10607000094005 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-17 |