LIPIFLOW ACTIVATOR II
Received Oct 12, 2019 · Event occurred Sep 20, 2019
Report 3008169506-2019-00008 · MDR key 9183159
Device
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
DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 10/10/2019. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: DEVICE HISTORY RECORD SHOWED NO RELATED NON-CONFORMITY OR DEVIATIONS ISSUED DURING MANUFACTURING THE ACTIVATOR LOT# 1804306. ALL DEVICES MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. AN EVALUATION OF THE RETURNED DEVICE WAS CONDUCTED. DEVICE WAS RETURNED OUTSIDE OF ITS ORIGINAL PACKAGING. THE PRIMARY PACKAGING WAS RECEIVED OPENED, BUT SEAL MARKINGS WERE VISIBLE ON THE TYVEK POUCH. NO DEBRIS/FIBERS OR ANY DAMAGE OBSERVED ON THE RETURNED PRODUCT. HOW AND WHEN THE REPORTED EVENT OCCURRED IS UNABLE TO BE DETERMINED. REPORTED ISSUE WAS CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING THE ACTIVATOR LOT# LOT# 1804306. ALL DEVICES MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. BASED ON THE INFORMATION RESULTS, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. JOHNSON & JOHNSON WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINT TYPES. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
Additional Manufacturer Narrative
(B)(6). 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
CUSTOMER REPORTED THAT UPON REMOVING PRODUCT FROM THE BOX THE INNER POUCH PACKAGE WAS ALREADY OPENED. THERE WAS NO PATIENT INVOLVEMENT.