MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-24 for LIPIFLOW ACTIVATOR II LFD-2000 manufactured by Johnson & Johnson Surgical Vision, Inc.
[124822072]
(b)(4). All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[124822073]
It was reported that patient had treatment with lipiflow system for dry eye on (b)(6) 2018 and presented on (b)(6) 2018 with hordeolum in the left eye. Patient was treated with antibiotics. It was reported that activator device was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008169506-2018-00102 |
| MDR Report Key | 7999502 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-24 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-09-25 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-10-26 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2018-10-24 |
| 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 | VALERIE SEDZICKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478567 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIPIFLOW ACTIVATOR II |
| Generic Name | LIPIFLOW |
| Product Code | ORZ |
| Date Received | 2018-10-24 |
| Model Number | LFD-2000 |
| Lot Number | 1806701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC |
| Manufacturer Address | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-24 |