EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.0/2.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542115407), received between Aug 12, 2022 and Jan 13, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT WITH ROTATION AND OVER/UNDER CORRECTION. DUE TO LOW VAULT WITH ROTATION AND OVER/UNDER CORRECTION, THE LENS WAS EXCHANGED FOR A SAME MODEL BUT LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED CAUSE OF THE EVENT WAS REPORTED AS "PATIENT RELATED FACTOR" AND "USE ERROR".

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

  MAUDE report 24062616 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED AN EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND IN THE SAME DAY DIFFERENT SURGERY A REPLACEMENT LENS OF A SHORTER LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS PATIENT RELATED FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087991 ↗
• InjuryMar 15, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -13.00/+2.0/089 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD). THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO AN OVERSIZED LENS. THE LENS WAS REPLACED WITH A SHORTER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545525 ↗
• InjuryDec 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. REPORTEDLY, "REBOUND IRITIS 1 MOUNTH POST OP ON AN EVO ICL ROTATION ADJUSTMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000207 ↗
• InjuryNov 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -13.00/2.0/088 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS EXPLANTED AND DISCARDED FOR AN UNKNOWN REASON. A REPLACEMENT LENS OF SHORTER LENGTH WAS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. 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 15832029 ↗
• InjuryAug 12, 2022Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -13.0/2.0/087 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED AND REMOVED ON (B)(6) 2022 , DUE TO THE LENS FLIPPED UPSIDE DOWN . THE REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15217845 ↗

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