EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-11.0/1.5) (REF VTICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542113502), received between Nov 15, 2022 and Sep 27, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1, -11.00/1.5/096 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). IT WAS REPORTED THAT THE LENS WAS EXPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830164 ↗
• InjurySep 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1, -11.00/1.5/096 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) AS A BACK UP LENS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830163 ↗
• InjuryDec 28, 2022Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -11.0/2.0/074 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S EYE. ON (B)(6) 2022, THE LENS WAS EXCHANGED DUE TO THE LENS BEING TOO SMALL AND LENS ROTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16065464 ↗
• InjuryNov 15, 2022Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM VTICM5_12.1 IMPLANTABLE COLLAMER LENS, -11.00/+1.5/093 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS REMOVED O (B)(6) 2022 DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT, BLURRED VISION AND REFRACTIVE CHANGE OVERTIME. THE LENS WAS REPLACED WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED. POST-OP THE INTRAOCULAR PRESSURE (IOP) WAS ELEVATED. INITIATED COMBIGAN BID AND PRED FORTE BID. THE ELEVATED IOP WAS RESOLVED AND WAS MEASURED WITHIN NORMAL RANGE ON (B)(6) 2022. THE CAUSE OF THE EVENT WAS DUE TO LENS WAS TOO SMALL.

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

  MAUDE report 15801908 ↗

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-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.
• 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-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.