ACRYSOF ULTRASERT AU00T0 (REF AU00T0.195)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ ASPHERIC IOL SP ACRYLIC FOLDABLELENS wUltraSert(TM) DELIVERY SYSTEM UV wBLUE LIGHT FILTER. 13.0mm LENGTH 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC PLANAR HAPTICS. · Class 3 · Implant
All models of AcrySof UltraSert (102)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652358262), received between Mar 28, 2023 and Nov 26, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Opacification” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Opacification1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Inflammation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2024Material Opacification; Material Opacification
A HEALTH CARE PROFESSIONAL REPORTED THAT 8 YEARS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD A VISIT TO SURGEON CLINIC BECAUSE OF VISUAL ACUITY DECREASE, WHERE SURGEON OBSERVED THAT THAT IOL WAS OPACIFIED. THE EXPLANTATION OF THE LENS WAS SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 20784735 ↗InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT DURING A CATARACT VITRECTOMY COMBINATION SURGERY, WHILE USING INTRAOCULAR LENS AND OPHTHALMIC VISCOSURGICAL DEVICE A PATIENT EXPERIENCED OPAQUE VITREOUS HUMOR AND IT WAS DIAGNOSED WITH PROBABLE INFLAMMATORY RESPONSE. THE LENS WAS EXPLANTED AND IMPLANTED A NEW ONE TO AVOID INFLAMMATORY REACTIONS. THE PATIENT WAS GIVEN WITH SYSTEMIC STEROIDS AND THE CONDITION IS IMPROVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation
MAUDE report 16627788 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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