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Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102810)Recalls & reported problems

Staar Surgical Company · Diopter: -13.0; Overall Diameter (Length): 12.1 mm · Class 3 · Implant

All models of Visian ICL (Implantable Collamer Lens) (96)

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 00841542102810), received between Dec 1, 2021 and Dec 1, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Misfocusing” (1 report).

8 other recalls cover devices cleared under the same FDA submission (P030016); they may or may not involve this specific model.

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

  • Misfocusing1
  • Off-Label Use1

Patient problems

  • Blurred Vision1
  • Cataract1

Recent adverse event reports

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

  • InjuryDec 1, 2021Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

    THE PATIENT INDICATED THE SURGEON IMPLANTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -13.00 DIOPTER, IN HIS LEFT EYE (OS) ON (B)(6) 2021. THE PATIENT REPORTED EXPERIENCING BLURRY/CLOUDY VISION ONE WEEK AFTER ICL IMPLANTATION, REPORTEDLY DUE TO PREDNISOLONE, WHICH WAS PRESCRIBED AFTER IMPLANTATION. THE PREDNISOLONE WAS DISCONTINUED. CATARACTS WERE OBSERVED. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: Blurred Vision; Cataract

    MAUDE report 12914025 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030016. One submission often covers many models, so check the product and lot details in each record.

  • Z-1480-2026 · Jan 21, 2026 · Open, Classified
    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
  • Z-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
  • Z-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-0466-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
  • Z-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
  • Z-0474-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
  • Z-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page