MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LIPIFLOW SEMI-PERMANENT CABLE

Model Number	CBL-2000
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing date is unknown.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
It was reported that the cables are burning out and they are turning dark.
Additional Manufacturer Narrative
Upon reviewing the complaint folder, it has been determined there was no visible signs of smoke or a burnt device and visual inspection found no evidence of burnt device.Based on our reportable criteria, this report is no longer a reportable event.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 3008169506-2020-00003.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: LIPIFLOW SEMI-PERMANENT CABLE
• Common Device Name: LIPIFLOW
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10871414
• Report Number: 3008169506-2020-00003
• Device Sequence Number: 19646717
• Product Code: ORZ
• UDI-Device Identifier: 00859623006711
• UDI-Public: (01)00859623006711(10)170914
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: CBL-2000
• Device Catalogue Number: 240100
• Device Lot Number: 170914
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1