FDA Adverse Event
Summary report: N
ACUVUE
MDR report key: 4299989
·
Received December 5, 2014
Report
- Report Number
- 1033553-2014-05001
- Date Received
- December 5, 2014
- Date of Event
- October 1, 2014
- Report Date
- December 5, 2014
- Manufacturer
- JOHNSON & JOHNSON VISION CARE, INC. ? US
- Product Code
- LPM
- PMA / PMN Number
- P040045
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VERIFICATION OF EMDR SUBMISSION FOR JOHNSON & JOHNSON VISION CARE, INC. ¿ US (VISTAKON). SUBMITTED FROM NEW SYSTEM. NO ACTUAL COMPLAINT OR ADVERSE EVENT FOR THIS REPORT.
Description of Event or Problem · 1
VERIFICATION OF EMDR SUBMISSION FOR VC. NOT A VALID COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 788358 | ACUVUE | LENSES, SOFT CONTACT, EXTENDED WEAR | LPM | JOHNSON & JOHNSON VISION CARE, INC. ? US | CYP | D006FKJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |