LIPIFLOW SEMI-PERMANENT CABLE
Received Dec 18, 2019 · Event occurred Nov 12, 2019
Report 3008169506-2019-00009 · MDR key 9491975
Device
Generic name
Lipiflow
Manufacturer
Johnson & Johnson Surgical Vision, Inc.Model number
CBL-2000Catalog number
CBL-2000
Lot number
170505
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
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.
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.
Description of Event or Problem
ACCOUNT REPORTED THAT CABLE HAD BURN MARKS ON IT.