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

Model Number CBL-2000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2019

Event Type  malfunction  

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 Description

Account reported that cable had burn marks on it.

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.

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
• Type of Device: LIPIFLOW
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9491975
• MDR Text Key: 171897080
• Report Number: 3008169506-2019-00009
• Device Sequence Number: 1
• Product Code: ORZ
• UDI-Device Identifier: 00859623006711
• UDI-Public: (01)00859623006711(10)170505
• Combination Product (y/n): Y
• PMA/PMN Number: K161357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1