MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC LIPIFLOW ACTIVATOR II

Model Number	LFD-2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Account reported a patient had bruising and swelling 8 days after a lipiflow treatment.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: LIPIFLOW ACTIVATOR II
• Common Device Name: LIPIFLOW
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 8203371
• Report Number: 3008169506-2018-00104
• Device Sequence Number: 18898280
• Product Code: ORZ
• UDI-Device Identifier: 00859623006414
• UDI-Public: (01)00859623006414(10)UNKNOWN
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LFD-2000
• Device Catalogue Number: 210000
• Device Lot Number: UNKNOWN/NOT PROVIDED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005