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lioli™ IOL Delivery System LIOLI-24Recalls & reported problems

Ast Products, Inc. · Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling · Class 1

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 10814899027027), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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

  • Off-Label Use1
  • Use of Device Problem1

Patient problems

  • Capsular Bag Tear1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 20, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

    REPORTER STATED ICL LENS WAS TORN ON INSERTION. DOCTOR NOTED LARGE TEAR IN ICL AFTER IMPLANT WITH THE INJECTOR. THE LENS CAPSULE WAS VIOLATED AND THE SURGEON ENDED UP DOING A REFRACTIVE LENS EXCHANGE.

    Patient problems: Capsular Bag Tear

    MAUDE report 17365434 ↗

Other Folders And Injectors, Intraocular Lens (Iol) devices

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Sources and updates

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