MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-29 for UNK-SOFT CONTACT LENSES manufactured by Johnson & Johnson Vision Care, Inc. ? Us.
| Report Number | 1057985-2019-00079 |
| MDR Report Key | 8947266 |
| Date Received | 2019-08-29 |
| Date of Report | 2019-09-20 |
| Date of Event | 2018-06-30 |
| Date Mfgr Received | 2019-09-20 |
| Device Manufacturer Date | 2017-07-21 |
| Date Added to Maude | 2019-08-29 |
| 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 | ROSE HARRELL |
| Manufacturer Street | 7500 CENTURION PARKWAY 7500 CENTURION PARKWAY |
| Manufacturer City | JACKSONVILLE FL 32256 |
| Manufacturer Country | US |
| Manufacturer Postal | 32256 |
| Manufacturer Phone | +904443364 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNK-SOFT CONTACT LENSES |
| Generic Name | UNK-SOFT CONTACT LENSES |
| Product Code | LPN |
| Date Received | 2019-08-29 |
| Model Number | NA |
| Catalog Number | UNK-SOFT CONTACT LENSES |
| Lot Number | UNK-UNK-SOFT CONTACT LENSES |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON VISION CARE, INC. ? US |
| Manufacturer Address | 7500 CENTURION PARKWAY JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-08-29 |