ACRYSOF ULTRASERT AU00T0 (REF AU00T0.235)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652358347), received between Nov 13, 2017 and Nov 13, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
- Sticking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2017Break; Detachment Of Device Component; Sticking
HAPTIC BROKE OFF. THESE ARE PRE-LOADED INSERTION DEVICES AND THE HAPTIC GOT STUCK IN DEVICE. A NEW ALCON IOL WITH ULTRASERT PRE-LOADED DELIVERY SYSTEM WAS OBTAINED AND INSERTED WITHOUT DIFFICULTY. NEW LENS IMPLANTED: LENS UV WITH BLUE LIGHT FILTER ULTRASERT 22.0D POWER 13MM LENGTH 6.0MM OPTIC AU00T0 ALCON - CAT# AU00T0.220, EXP 2-29-2020.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7024567 ↗
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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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