MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-30 for LIPIFLOW ACTIVATOR II LFD-2000 manufactured by Johnson & Johnson Surgical Vision, Inc.
[125599796]
Date of event unknown. Patient reported that stye formed post treatment and the best estimate is after (b)(6) 2015. Lot#: unknown/not provided. Expiration date: unknown as product lot number was not provided. 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. (b)(4). 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
[125599797]
Patient reported that had lipiflow procedure done in (b)(6) 2015 at (b)(6) institute in (b)(6). During the procedure patient reported that technician had a hard time getting the applicator under the lid. Patient stated that because of that the technician kept putting the applicator it in & out of the right eye. Patient initially reported that after a few weeks post treatment a stye like bump developed that required the eye doctor cut it open however, during follow up the patient stated this incident occurred around (b)(6) or (b)(6) of 2016 which is more that few weeks post treatment. Patient also reported that around (b)(6)/(b)(6) 2016 a stye formed in the same eye (right) same location and also had to be cut open.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008169506-2018-00103 |
| MDR Report Key | 8022292 |
| Report Source | CONSUMER |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-10-01 |
| Date Added to Maude | 2018-10-30 |
| 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 | 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 | 2018-10-30 |
| Model Number | LFD-2000 |
| Lot Number | UNKNOWN |
| 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. Required No Informationntervention | 2018-10-30 |