MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-19 for BIOFINITY SPHERE (COMFILCON A) manufactured by Coopervision Manufacturing, Ltd..
[176029824]
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
[176029825]
Information received from the distributor. The patient alleges that they experienced an infection of the eye that led to a corneal transplant. Good faith efforts have been made to obtain additional info without success, additional info is unknown. This event is being reported in an abundance of caution due to lack of medical info, incomplete diagnosis, and unknown resolution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614392-2020-00002 |
| MDR Report Key | 9604891 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2017-06-18 |
| Date Added to Maude | 2020-01-19 |
| 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 CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 5857569874 |
| 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 | 2020-01-19 |
| Lot Number | 11317050055508 |
| 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 MANUFACTURING, LTD. |
| Manufacturer Address | SOUTH POINT HAMBLE UNIT 2 SOUTHAMPTOM, HAMPSHIRE SO314RF UK SO31 4RF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-19 |