LIPIFLOW THERMAL PULSATION SYSTEM CONSOLE
Received Jul 2, 2019 · Event occurred May 30, 2019
Report 3008169506-2019-00002 · MDR key 8756252
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
CORRECTION: H4 - MANUFACTURING DATE - THE MANUFACTURING SITE REPORTED THAT THE MANUFACTURING DATE FOR THE DEVICE IS 3/13/2019. H3 OTHER TEXT : PLACEHOLDER.
Additional Manufacturer Narrative
DATE RECEIVED BY MANUFACTURER - IT WAS REPORTED IN THE FOLLOW UP THAT THE DATE WAS 2/13/2019 HOWEVER, THERE WAS A TYPOGRAPHICAL ERROR IN THE YEAR. THE CORRECT DATE IS 2/13/2020.
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 EVALUATED BY MFR: 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 A PATIENT HAD LIPIFLOW PROCEDURE ON (B)(6) 2019 AND WAS FINE POST TREATMENT. CUSTOMER CALLED BACK THE ACCOUNT ON (B)(6) 2019 AND REPORTED THAT WAS NOT FEELING WELL. SURGEON ADVISE PATIENT TO COME BACK IN ON (B)(6) 2019 AND DURING THAT VISIT PHYSICIAN DETERMINED PATIENT HAD INTERNAL HORDEOLUM.