ACRYSOF ULTRASERT AU00T0 (REF AU00T0.180)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652358231), received between Dec 23, 2016 and Jul 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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
- Failure to Deliver1
- Material Protrusion/Extrusion1
- Mechanics Altered1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2024Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE LENS DID NOT ENTER THE GUN BUT REMAINED IN THE CHAMBER. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO BE CONTACTED.
Patient problems: Insufficient Information
MAUDE report 19680520 ↗MalfunctionDec 23, 2016Material Protrusion/Extrusion; Mechanics Altered
A CUSTOMER REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS TILTED IN THE PATIENT'S EYE AND THAT THE FRONT HAPTIC WAS PROTRUDING OUT OF THE IRIS. THE IOL WAS IMPLANTED FIVE WEEKS PRIOR TO REPORTING THE EVENT. A SECOND PROCEDURE WAS SCHEDULED TO REPOSITION OR EXPLANT THE IOL. CURRENT PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.
Patient problems: Foreign Body In Patient; Visual Impairment
MAUDE report 6202715 ↗
Other intraocular lens devices
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- 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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