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	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing date 5/2017.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 that cable had burn marks on it.
Additional Manufacturer Narrative
Device evaluation: 1 sealed cable was received within original packaging - reported lot number confirmed.The products were returned within their original box that was opened.A visual inspection was performed on the returned product.The visual inspection of the product reveals brown/dark grey discoloration along the length of the cable.How and when these discolorations were introduced cannot be determined.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information 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 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: 9491975
• Report Number: 3008169506-2019-00009
• Device Sequence Number: 16607778
• Product Code: ORZ
• UDI-Device Identifier: 00859623006711
• UDI-Public: (01)00859623006711(10)170505
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 11/05/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CBL-2000
• Device Catalogue Number: CBL-2000
• Device Lot Number: 170505
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 10/25/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/17/2020; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005