ACRYSOF ULTRASERT AU00T0 (REF AU00T0.080)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652358033), received between Mar 3, 2021 and Mar 3, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED FOLLOWING THE IMPLANT OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED A SMUDGE IN HER VISION. THE SURGEON REPORTS A BUBBLE LIKE AREA IN THE CENTER OF THE LENS AS WELL AS THE TOP PART OF THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 11404484 ↗
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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