MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-07-29 for BLINK REVITALENS 09608X manufactured by Johnson & Johnson Surgical Vision, Inc..
| Report Number | 3004178847-2019-00011 |
| MDR Report Key | 8839235 |
| Report Source | CONSUMER |
| Date Received | 2019-07-29 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-06-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-06-07 |
| Device Manufacturer Date | 2018-07-14 |
| Date Added to Maude | 2019-07-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | 4TH AVE HZ ECON/TECH DEVELOP. ZONE |
| Manufacturer City | HANGZHOU 310018 |
| Manufacturer Country | CN |
| Manufacturer Postal Code | 310018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLINK REVITALENS |
| Generic Name | SOLUTIONS |
| Product Code | LPN |
| Date Received | 2019-07-29 |
| Model Number | 09608X |
| Lot Number | ZD06334 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-29 |