DUOVISC 8065183150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380651831506), received between Apr 23, 2021 and May 28, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Particulates” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2021Particulates; Particulates

  A CUSTOMER REPORTED THAT A VISCOELASTIC PRODUCT WAS USED DURING CATARACT SURGERY AFTER WHICH A FIBER WAS NOTED INSIDE OF THE EYE UPON THE FIRST POST-OPERATIVE FOLLOW-UP. THE RETAINED FIBER HAD TO BE REMOVED FROM THE EYE ON A LATER DATE. CURRENTLY, NO PATIENT HARM IS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11903548 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT MULTIPLE PATIENTS HAD AN INFECTION. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED HAS NOW IDENTIFIED THE PATIENT ASSOCIATED WITH THIS REPORT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IN THE LEFT EYE (OS) AFTER A CATARACT SURGERY. THE PATIENT WAS REFERRED TO A RETINA CENTER FOR FOLLOW-UP.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11890253 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT MULTIPLE PATIENTS HAD AN INFECTION. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED HAS NOW IDENTIFIED THE PATIENT ASSOCIATED WITH THIS REPORT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) IN THE LEFT EYE (OS) AFTER A CATARACT SURGERY. THE PATIENT WAS REFERRED TO A RETINA CENTER FOR FOLLOW-UP.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11890136 ↗
• 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 11760201 ↗
• 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 11760198 ↗
• 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 11719004 ↗
• 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 11718989 ↗
• 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 11713801 ↗
• 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 11713344 ↗