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Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542103138)Recalls & reported problems

Staar Surgical Company · Diopter: -15.5; Overall Diameter (Length): 12.6 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
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542103138), received between Feb 21, 2018 and Apr 13, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

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

  • Device Operates Differently Than Expected2

Patient problems

  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 13, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER INDICATED THAT A 12.6 MM MICL12.6, -15.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS TORN DURING LOADING. THE REPORTER STATED THAT ALTERNATE FORCEPS WERE USED TO LOAD THE LENS SINCE THEY ONLY HAD ONE FORCEP FOR VISIAN ICLS AND THE FORCEP WAS BROKEN WHEN LOADING THE PRIMARY LENS. THE SURGEON DECIDED TO USE A SIMILAR FORCEP AND THE LENS WAS TORN. THERE WAS NO PATIENT CONTACT. THE REPORTER STATED THAT THE CAUSE OF EVENT WAS A MECHANICAL ERROR, COULD NOT LOAD THE LENS CORRECTLY.

    Patient problems: No Patient Involvement

    MAUDE report 7430699 ↗
  • InjuryFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

    A 12.6 MM MICL12.6, -15.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS RETURNED DAMAGED TO THE MANUFACTURER. ATTEMPTS AT OBTAINING ADDITION INFORMATION HAVE BEEN UNSUCCESSFUL.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7286007 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
  • Z-0466-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
  • Z-0474-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
  • Z-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
  • Z-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

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