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EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-14.5/1.0) (REF VTICMO 12.6)Recalls & reported problems

Staar Surgical Company · VTICMO - Diopter: -14.5; Cylinder 1.0; Overall Diameter (Length): 12.6 · Class 3 · Implant

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

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542120296), received between Oct 11, 2022 and Dec 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (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

  • No Apparent Adverse Event1
  • Optical Problem1

Patient problems

  • Dry Eye(s)1
  • No Clinical Signs, Symptoms or Conditions1
  • Visual Disturbances1

Recent adverse event reports

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

  • MalfunctionDec 21, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT ON (B)(6) 2022 A 12.6MM, VTICMO12.6, -14.5/1.0/095 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE RIGHT EYE (OD). THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY. THERE WAS NO PATIENT INJURY. PROBLEM RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16026402 ↗
  • MalfunctionOct 11, 2022Optical Problem; Optical Problem

    THE REPORTER INDICATED THAT ON (B)(6) 2022 A 12.6MM, VTICMO12.6, -14.5/1.0/094 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED AS A REPLACEMENT LENS. IT WAS REPORTER THAT IT RESOLVED THE PROBLEM BUT FOR STATUS OF THE EYE (SIGNS/SYMPTOMS) DRYNESS AND FLOATERS WERE REPORTED. FOR PATIENTS CURRENT CONDITION IT WAS REPORTED THAT THE EYE IS S/P ICL AND DOING WELL, NO INTERVENTION WAS NECESSARY AND IT HAS IMPROVED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Dry Eye(s); Visual Disturbances

    MAUDE report 15583155 ↗

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-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-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-0466-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

Other Phakic Toric Intraocular Lens devices

All Phakic Toric Intraocular Lens devices →

Sources and updates

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