Amvisc 59081LRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00757770495658), received between Feb 8, 2023 and Jun 26, 2025 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN UNCOMPLICATED INTRAOCULAR LENS (IOL) IMPLANTATION IN THE LEFT EYE, THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY, RED EYE, POSITIVE TYNDAL'S AND SUSPECTED TASS. FIVE (5) DAYS POST PROCEDURE, A SECONDARY INTERVENTION WAS PERFORMED AT ANOTHER HEALTHCARE FACILITY AND THE IOL WAS EXPLANTED AND REPLACED WITH AN UNKNOWN IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Red Eye(s); Toxic Anterior Segment Syndrome (TASS); Visual Impairment

  MAUDE report 22335615 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ONE DAY POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT (OD) EYE, THE PATIENT EXPERIENCED SYMPTOMS THAT WERE LATER DIAGNOSED AS TASS. AN INTRAOCULAR INJECTION WAS ADMINISTERED. IN THE SURGEON'S OPINION, THE LIKELY CAUSE OF THE EVENT WAS THE IOL. THE PATIENT'S OUTCOME IS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED.

  Patient problems: Loss of Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20352358 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY IN THE UK REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING UNCOMPLICATED CATARACT SURGERY IN THE RIGHT EYE. THE IOP PRIOR TO SURGERY WAS 20MMHG. THE IOP WAS ELEVATED POSTOPERATIVELY AT 52MMHG AND THE IOP WAS STILL ELEVATED FOUR (4) WEEKS POST PROCEDURE WITH AN IOP OF 35 MMHG. PATIENT WAS TREATED WITH FULL MEDICAL TREATMENT AND IS DUE TO HAVE A PRESERFLO DEVICE. THE PATIENT HAS NOT RECOVERED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16384956 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY IN THE UK REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING UNCOMPLICATED CATARACT SURGERY IN THE RIGHT EYE. THE IOP PRIOR TO SURGERY WAS 18MMHG. THE IOP WAS ELEVATED POSTOPERATIVELY AT 58MMHG AND THE IOP WAS STILL ELEVATED FOUR (4) WEEKS POST PROCEDURE WITH AN IOP OF 64 MMHG. PATIENT WAS TREATED WITH FULL MEDICAL TREATMENT AND IS DUE TO HAVE A PRESERFLO DEVICE. THE PATIENT HAS NOT RECOVERED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16384955 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING UNCOMPLICATED CATARACT SURGERY IN THE LEFT EYE. THE IOP PRIOR TO SURGERY WAS 24MMHG. THE INCREASED IOP WAS FIRST NOTICED FOUR (4) DAYS AFTER THE SURGERY WITH AN IOP OF 57MMHG WHICH LASTED FOR FOUR (4) WEEKS AND IS NOTED AS STILL HIGH. TREATED WITH AN ANTERIOR CHAMBER (AC) WASH. THE PATIENT HAS NOT RECOVERED WITH AN IOP OF 48 MMHG.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16324756 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING CATARACT SURGERY WITH A SYNECHIOLYSIS PROCEDURE IN THE LEFT EYE. THE IOP PRIOR TO SURGERY WAS 23MMHG. THE IOP WAS ELEVATED POSTOPERATIVELY AT DAY 1 AT 50MMHG AND THE INCREASED IOP LASTED FOR FOUR (4) WEEKS AND WAS TREATED WITH A PRESERFLO DEVICE. THE PATIENT HAS NOT RECOVERED AND THE IOP IS CURRENTLY AT 33 MMHG.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16324726 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING UNCOMPLICATED CATARACT SURGERY IN THE LEFT EYE. THE IOP PRIOR TO SURGERY WAS 17MMHG. THE IOP WAS ELEVATED POSTOPERATIVELY AT DAY 1 AT 63MMHG AND THE INCREASED IOP LASTED FOR FOUR (4) WEEKS. IT WAS TREATED WITH A PRESERFLO DEVICE. THE PATIENT HAS NOW RECOVERED AND THE IOP IS CURRENTLY AT 14 MMHG.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16324514 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING UNCOMPLICATED CATARACT SURGERY IN THE RIGHT EYE. THE IOP PRIOR TO SURGERY WAS 15MMHG. THE IOP WAS ELEVATED POSTOPERATIVELY AT 60MMHG AND THE INCREASED IOP LASTED FOR EIGHT (8) WEEKS AND IS CURRENTLY HIGH AT 32 MMHG. PATIENT WAS TREATED WITH MAXIMUM MEDICAL TREATMENT. THE PATIENT HAS NOT RECOVERED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16324440 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING CATARACT SURGERY IN THE RIGHT EYE. THE PATIENT HAD A BLEED INTO THE ANTERIOR CHAMBER (AC) DURING THE SURGERY. THE IOP PRIOR TO SURGERY WAS 24MMHG. THE IOP WAS ELEVATED POSTOPERATIVELY AT DAY 1 AT 52MMHG AND THE INCREASED IOP LASTED FOR THREE (3) WEEKS. IT WAS TREATED WITH A PRESERFLO DEVICE. THE PATIENT HAS NOT RECOVERED AS THE IOP IS CURRENTLY AT 40 MMHG.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16324324 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE FACILITY REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) FOLLOWING UNCOMPLICATED CATARACT SURGERY IN THE LEFT EYE. THE IOP PRIOR TO SURGERY WAS 15MMHG. THE INCREASED IOP WAS FIRST NOTICED THREE (3) DAYS AFTER THE SURGERY WITH AN IOP OF 59MMHG WHICH LASTED FOR FOUR (4) WEEKS. PATIENT WAS TREATED WITH A PRESERFLO DEVICE. THE PATIENT HAS NOW RECOVERED WITH AN IOP OF 15 MMHG.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16322299 ↗