MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-25 for PROCLEAR 1 DAY (OMAFILCON A) manufactured by Coopervision Carribean Corporation.
| Report Number | 2640128-2019-00007 |
| MDR Report Key | 9240045 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-25 |
| Date of Report | 2019-11-22 |
| Date Mfgr Received | 2019-09-27 |
| Device Manufacturer Date | 2018-04-25 |
| Date Added to Maude | 2019-10-25 |
| 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 CARRIBEAN CORPORATION |
| Manufacturer Street | 500 ROAD 584 LOT 7 |
| Manufacturer City | AMUELAS INDUSTRIAL PARK, 00795 |
| Manufacturer Postal Code | 00795 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCLEAR 1 DAY (OMAFILCON A) |
| Generic Name | PROCLEAR 1 DAY (OMAFILCON A) |
| Product Code | MVN |
| Date Received | 2019-10-25 |
| Returned To Mfg | 2019-10-01 |
| Lot Number | 3614503696 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERVISION CARRIBEAN CORPORATION |
| Manufacturer Address | 500 ROAD 584 LOT 7 AMUELAS INDUSTRIAL PARK, JUANA DIAZ 00795 00795 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-10-25 |