MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-06 for BIOFINITY SPHERE (COMFILCON A) manufactured by Coopervision Manufacturing, Ltd..
[174922967]
No issues or nonconformance's were found and no trends were identified, no root cause could be established. The relationship between the coopervision device and the event is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[174922968]
The patient states that upon inserting a new contact lens she experienced severe eye pain and redness which developed into an ulcer. The patient sought medical treatment from her general practitioner who diagnosed the ulcer and referred the patient to an eye specialist. The patient opted not to seek further care but discontinued lens use and the incident is fully resolved after approximately three weeks. Good faith efforts have been made to obtain additional information without success, additional 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 | 9614392-2020-00001 |
| MDR Report Key | 9549592 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-04 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2019-12-05 |
| Date Added to Maude | 2020-01-06 |
| 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 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 | 2020-01-06 |
| Returned To Mfg | 2019-12-18 |
| Lot Number | 12907050075015 |
| 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 | 2020-01-06 |