MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-14 for ACUVUE? OASYS? PH manufactured by Johnson & Johnson Vision Care, Inc. ? Ireland.
| Report Number | 9617710-2020-00003 |
| MDR Report Key | 9588783 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-27 |
| Date of Event | 2019-11-13 |
| Date Mfgr Received | 2019-12-27 |
| Device Manufacturer Date | 2017-09-25 |
| Date Added to Maude | 2020-01-14 |
| 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 |
| Manufacturer City | JACKSONVILLE FL 32256 |
| Manufacturer Country | US |
| Manufacturer Postal | 32256 |
| Manufacturer Phone | 9044433364 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUVUE? OASYS? |
| Generic Name | LENSES, SOFT CONTACT, EXTENDED WEAR |
| Product Code | LPM |
| Date Received | 2020-01-14 |
| Model Number | NA |
| Catalog Number | PH |
| Lot Number | L003C3P |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON VISION CARE, INC. ? IRELAND |
| Manufacturer Address | ONE TECHNOLOGICAL PARK PLASSEY LIMERICK EI |
| Product Code | --- |
| Date Received | 2020-01-14 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-01-14 |