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 2018-12-28 for LIPIFLOW ACTIVATOR II LFD-2000 manufactured by Johnson & Johnson Surgical Vision, Inc.
[131639888]
Date of event unknown. Lot#: unknown/not provided. Expiration date: unknown as product lot number was not provided. Udi #: a complete udi # is unknown as product lot number was not provided. Device manufacture date: unknown, as the lot number of the device was not provided. A review of records related to the device including labeling, complaint trending, and risk documentation will be performed. Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed. All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[131639889]
Account reported a patient had bruising and swelling 8 days after a lipiflow treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008169506-2018-00104 |
| MDR Report Key | 8203371 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-28 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-12-28 |
| 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 | ABBOTT MEDICAL OPTICS |
| 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 | 2018-12-28 |
| Model Number | LFD-2000 |
| Lot Number | UNKNOWN/NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| 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 | SANTA ANA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-28 |