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EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-7.0) (REF VICM5 12.1)Recalls & reported problems

Staar Surgical Company · VICM5 - Diopter: -7.0; Overall Diameter (Length): 12.1 · Class 3 · Implant

All models of EVO/EVO+VISIAN Implantable Collamer Lens (1030)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841542118897), received between Aug 28, 2023 and Aug 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

  1. Sep 29, 2023Class IIOpen, Classified

    Their is a potential that intraocular implant devices may not meet specifications.

    Z-0464-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Device problems

  • Inadequacy of Device Shape and/or Size1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryAug 28, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS OF -7.00 DIOPTER WAS PART OF A LENS EXCHANGE DUE TO THE LENS BEING TOO SMALL, DOCTOR WENT WITH A 12.6MM LENS INSTEAD. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17638493 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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