EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 13.2 (-15.0/1.5) (REF VTICMO 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542120937), received between Nov 23, 2022 and Nov 23, 2022 — classified as 2 injuries.

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

Recent adverse event reports

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

• InjuryNov 23, 2022Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size; Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -15.00/+1.5/072 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO EXCESSIVE VAULTING, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND BLURRED VISION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 15856830 ↗
• InjuryNov 23, 2022Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size; Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS, -15.00/+1.5/106 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO EXCESSIVE VAULTING, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES AND BLURRED VISION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 15856726 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.