DUOVISC 8065183135Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380651831353), received between Apr 23, 2021 and May 3, 2021 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED AN "OUTBREAK" OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AT THEIR FACILITY. IN A FOLLOW UP WITH THE CUSTOMER, IT WAS REPORTED THAT THERE WERE FOUR PATIENTS WHO PRESENTED WITH TASS FOLLOWING OCULAR SURGERY. THERE WERE TWO SURGEON'S INVOLVED. ALL FOUR OF THE TASS CASES ALSO HAD GLAUCOMA AND THREE OF THE PATIENT'S HAD COMBINED CATARACT AND GLAUCOMA PROCEDURE. IT IS UNKNOWN AT THIS TIME WHICH SURGERY WAS PERFORMED ON WHICH PATIENT. THIS FILE REPRESENTS ONE OF THE FOUR PATIENTS.

  Patient problems: Inflammation

  MAUDE report 11760196 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED AN "OUTBREAK" OF TASS AT THEIR FACILITY. IN A FOLLOW UP WITH THE CUSTOMER, IT WAS REPORTED THAT THERE WERE FOUR PATIENTS WHO PRESENTED WITH TASS FOLLOWING OCULAR SURGERY. THERE WERE TWO SURGEON'S INVOLVED. ALL FOUR PATIENTS ASSOCIATED WITH THIS REPORT OF TASS HAD A HISTORY OF GLAUCOMA. THE EXACT PROCEDURE PERFORMED ON ANY ONE PATIENT REMAINS UNCONFIRMED. THIS FILE REPRESENTS TWO OUT OF THE FOUR PATIENTS.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11718992 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED AN "OUTBREAK" OF TASS AT THEIR FACILITY. IN A FOLLOW UP WITH THE CUSTOMER, IT WAS REPORTED THAT THERE WERE FOUR PATIENTS WHO PRESENTED WITH TASS FOLLOWING OCULAR SURGERY. THERE WERE TWO SURGEONS INVOLVED. ALL FOUR PATIENTS ASSOCIATED WITH THIS REPORT OF TASS HAD A HISTORY OF GLAUCOMA. THE EXACT PROCEDURE PERFORMED ON ANY ONE PATIENT REMAINS UNCONFIRMED. THIS FILE REPRESENTS ONE OF THE FOUR PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713296 ↗