EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-7.5/1.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840311311415), received between May 31, 2023 and Aug 20, 2026 — classified as 11 injuries, 1 malfunction.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced refractive surprise and lens rotation. The lens was later repositioned. Cause of the event is unknown. Additional information was requested. No further information is available at this time. This file will be re-opened if additional information is provided.

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

  MAUDE report 50358907 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT WITH SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. LENS WAS EXPLANTED AND REPLACEMENT LENS OF A SHORTER LENGTH WAS LATER IMPLANTED. PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE IMPLANTED LENS WAS THE WRONG SIZE. A SMALLER LENS SHOULD HAVE BEEN SELECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25739982 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE CHANGE OVERTIME. THE LENS WAS EXCHANGED FOR A STRONGER POWER BUT SAME MODEL AND LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 25660476 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LENS ROTATION . A REPOSITIONING WAS ATTEMPTED. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328661 ↗
• InjuryJul 24, 2025Adverse 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 EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, AND ELEVATED IOP. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS DEVICE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 22589385 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND ELEVATED IOP WITHOUT PUPIL BLOCK AND ANGLE CLOSURE. DUE TO EXCESSIVE VAULT AND ELEVATED IOP WITHOUT PUPIL BLOCK AND ANGLE CLOSURE, THE LENS WAS REMOVED. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 20659391 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19779768 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -07.50/+1.5/090 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2024. THE LENS WAS EXPLANTED ON (B)(6) 2024 DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. THE LENS WAS REPOSITIONED ON (B)(6) 2024 BUT THE PROBLEM WAS NOT RESOLVED AND THE LENS WAS REMOVED. THE LENS WAS REPLACED WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995882 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -7.5/1.5/087 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. THE PATIENT ALSO EXPERIENCED LENS DISLOCATION/SUBLUXATION. ON (B)(6) 2024 THE LENS WAS EXCHANGED WITH A SAME LENGTH LENS AND THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS USER ERROR WITH NO DEVICE CAUSALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871114 ↗
• InjuryMar 1, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS -7.50/1.5/171 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED VERTICALLY INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822019 ↗
• MalfunctionFeb 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -07.50/+1.5/051 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT #: (B)(4). BUT THE PROBLEM WAS NOT RESOLVED, THE LENS STILL HAD A LOW VAULT. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670928 ↗
• InjuryMay 31, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF A -7.5/1.5/090 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. BLURRED VISION AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS OBSERVED. DIAGNOSTICS WERE PERFORMED. ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS WAS PERFORMED, AND AN ADDITION OF ORAL STEROIDS AND OINTMENTS WERE PRESCRIBED. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 17035361 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.