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Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102896)Recalls & reported problems

Staar Surgical Company · Diopter: -3.5; 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
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 00841542102896), received between Oct 25, 2016 and Oct 25, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

  • Inadequacy of Device Shape and/or Size1

Patient problems

  • Glaucoma1
  • Intraocular Pressure Increased1
  • No Code Available1

Recent adverse event reports

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

  • InjuryOct 25, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER STATED THAT THE SURGEON IMPLANTED A 12.6MM MICL12.6 LENS, -3.50 DIOPTER, IN THE PATIENT'S RIGHT EYE ON (B)(6) 2016. FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED NARROWING OF THE ANGLE AND SHALLOWING OF THE ACD. ON (B)(6) 2016, THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) AND CLOSED ANGLE GLAUCOMA DUE TO EXCESSIVE VAULTING OF THE LENS. THE PATIENT RECEIVED A YAG PERIPHERAL IRIDOTOMY, AND THE LENS WAS EXPLANTED. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

    Patient problems: Glaucoma; Intraocular Pressure Increased; No Code Available

    MAUDE report 6054107 ↗

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

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

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