TotalVisc TVISC20Recalls & reported problems
Bausch & Lomb Incorporated · TotalVisc Dual Unit OVD · Class 3
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770601735), received between Feb 25, 2025 and Dec 22, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Intraocular Pressure Increased2
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A HIGH INTEROCULAR PRESSURE (IOP) OF 66 AFTER USING THE VISCOELASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Patient problems: Intraocular Pressure Increased
MAUDE report 23867964 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A HIGH INTEROCULAR PRESSURE (IOP) OF 66 AFTER USING THE VISCOELASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Patient problems: Intraocular Pressure Increased
MAUDE report 23867411 ↗InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ONE DAY POST AN UNCOMPLICATED CATARACT EXTRACTION AND IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT¿S VISUAL ACUITY WAS 20/30. THE PATIENT¿S VISUAL ACUITY DECREASED OVER THE NEXT WEEK AND A HALF AND THE IOL WAS OBSERVED TO BE WHITE AND OPAQUE. AN INTRAOCULAR INJECTION OF ANTIBIOTICS WAS ADMINISTERED AS A PRECAUTION. ONE MONTH AFTER IMPLANT, THE SURGEON ATTEMPTED TO REMOVE THE IOL, BUT OBSERVED AN INFLAMMATORY MEMBRANE, ALLEGEDLY AS A RESULT OF TASS, AND REMOVED THE MEMBRANE. THE IOL WAS DETERMINED TO BE CLEAR AND REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.
Patient problems: Toxic Anterior Segment Syndrome (TASS); Visual Impairment
MAUDE report 21463095 ↗
Other Aid, Surgical, Viscoelastic devices
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- HEALON DUET PRO II 10300016Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC1 recall0 reports
- HEALON ENDOCOAT VT585UJohnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC22 reports
- HEALON 5 10290051Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC20 reports
- HEALON GV PRO 10240014Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC15 reports
- Amvisc 59081LBausch & Lomb Incorporated · Aid, Surgical, Viscoelastic10 reports
- HEALON DUET PRO 10240016Johnson & Johnson Surgical Vision, Inc. · AID, SURGICAL, VISCOELASTIC9 reports
- DUOVISC 8065183150Alcon Laboratories, Inc. · Aid, Surgical, Viscoelastic9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.