LIPIFLOW ACTIVATOR II
Received Mar 27, 2020 · Event occurred Mar 4, 2020
Report 3008169506-2020-00001 · MDR key 9892372
Device
Generic name
Lipiflow Activator Ii
Manufacturer
Johnson & Johnson Surgical Vision, Inc.Model number
LFD-2000Catalog number
LFD-2000
Lot number
1907015
Product problems
- Delivered as Unsterile Product
- Delivered as Unsterile Product
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
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.
Additional Manufacturer Narrative
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
IT WAS REPORTED THAT PRODUCT PACKAGING HAD AN OPENING/TEAR UPON INSPECTION. CANNOT CONFIRM IF IT WAS RECEIVED AS IS OR IF IT WAS DUE TO MISHANDLING AT THE CUSTOMER SITE. THE PRODUCT WAS NOT USED.