REVANESSE VERSA+ (WITH LIDOCAINE)

Additional Manufacturer Narrative

CLINIC WAS CONTACTED FOR MORE INFORMATION ON 11-MAY-2026 AS VERY LIMITED INFORMATION WAS PROVIDED ON 11-MAY-2026; ON 25-MAY-2026, THE CLINIC HAS REACHED TO PMT HOWEVER, THE CLINIC DID NOT RESPOND TO PMT'S ALL QUESTIONS. PMT HAS REACHED OUT TO CLINIC FOR MORE INFORMATION ON 25-MAY-2026, 29-MAY-2026, 04-JUN-2026, AND 11-JUN-2026 HOWEVER, NO RESPONSE RECEIVED; AS RESULT, PMT FINALIZED INVESTIGATIONS (WITH DELAY) WITH THE INFORMATION AVAILABLE. THIS CASE IS REPORTED VOLUNTARILY AS THERE IS NO EVIDENCE THAT ADVERSE EVENT IS ASSOCIATED WITH USE OF DEVICE.

Description of Event or Problem

NARRATIVE FROM CLINIC: ON (B)(6) 2026, PATIENT COMES IN TODAY FOLLOWING INJECTION OF FILLER UNDER THE EYES APPROXIMATELY TWO MONTHS AGO. PATIENT EXPERIENCED A DELAYED INFLAMMATORY RESPONSE FROM FILLER PLACEMENT WITH SWELLING AND IRRITATION OF THE INJECTED TISSUES, BEGINNING APPROXIMATELY THREE WEEKS AFTER INJECTION AND CONTINUING UNTIL PRESENT DAY. PATIENT WAS EVALUATED AND INSTRUCTED TO PERFORM TWICE DAILY LYMPHATIC DRAINAGE MASSAGE AS WELL AS TOPICAL SERUMS AIMED AT REDUCING SWELLING. PATIENT AGAIN RETURNED LAST WEEK WITH ONGOING SWELLING AND OPTED TO HAVE THE FILLER DISSOLVED USING HYLINEX. TODAY, THE PATIENT NOTES THAT WHILE THE SWELLING AND PUFFINESS UNDER HER EYES IS IMPROVED NOW THAT THE FILLER HAS BEEN REMOVED, SHE HAS NOTICED A SIGNIFICANT INCREASE IN THE HYPERPIGMENTATION UNDER HER EYES. WHILE THIS IS NOT NOTABLE BETWEEN OUR BEFORE AND AFTER PICTURES. WE HAVE IDENTIFIED THAT PICTURES WERE TAKEN IN DIFFERENT LIGHTING AND DIFFERENT STATES OF MAKEUP APPLICATION, MAKING IDENTIFICATION OF THIS COMPLICATION DIFFICULT FROM A VISUAL PERSPECTIVE. TODAY, A SMALL AMOUNT OF HYLINEX WAS ONCE AGAIN INJECTED UNDER THE EYES TO REMOVE REMAINING FILLER FROM THE UNDERLYING TISSUES. ADDITIONALLY, THE PATIENT'S AREA OF CONCERN WAS MICRONEEDLED USING A SERUM CONTAINING HYALURONIC ACID, VITAMIN C, AND GLUTATHIONE. THE PROCEDURE WAS PERFORMED AT 0.5 MILLIMETER DEPTH WITH SLIGHT ERYTHEMA ACHIEVED AND TOLERATED WELL. SERUM WAS APPLIED TOPICALLY, AND ADDITIONAL SERUM WAS SENT HOME WITH THE PATIENT WITH INSTRUCTIONS TO APPLY EACH HOUR FOR THE REMAINDER OF THE DAY. LASTLY, COMMA PATIENT WAS INSTRUCTED TO APPLY ONE PERCENT HYDROCORTISONE CREAM TO THE AFFECTED AREA TWICE DAILY BEGINNING TOMORROW TIMES THREE DAYS TO PREVENT ANY FURTHER HYPERPIGMENTATION DRIVEN BY AN INFLAMMATORY RESPONSE SECONDARY TO THE MICRONEEDLING.