EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-10.5/3.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311312313), received between Apr 25, 2023 and May 1, 2026 — classified as 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION. THE LENS WAS EXPLANTED. ON THE SAME DAY IN A SEPARATE SURGERY THE LENS WAS REPLACED FOR A SAME MODEL, POWER AND LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS IS UNKNOWN.

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

  MAUDE report 25057149 ↗
• InjurySep 12, 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. THE LENS WAS REPOSITIONED, BUT THE PROBLEM WAS NOT RESOLVED. THE LENS WAS EXCHANGED WITH A DIFFERENT POWER & MODEL OF A SHORTER LENGTH LENS & THE PROBLEM WAS RESOLVED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23044632 ↗
• InjuryMay 9, 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 EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. AT A LATER DATE THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR.

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

  MAUDE report 21997453 ↗
• InjuryNov 11, 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 LOW VAULT. LENS REMAINS IMPLANTED WITH PLANNED EXCHANGE. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653942 ↗
• InjuryAug 6, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY." 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924505 ↗
• InjuryMay 15, 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, -10.50/+3.0/092 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REPOSITIONED ON 27-OCT-2023 BUT THE PROBLEM WAS NOT RESOLVED. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH BUT DIFFERENT POWER LENS BUT THE PROBLEM WAS NOT RESOLVED. SEE MFR. REPORT # 2023826-2024-02173 FOR REPLACEMENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323044 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.50/+3.0/090 (SPHERE/CYLINDER/AXIS), INTO THE PATIENT`S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT HAD DIFFICULTY READING PHONE AND COMPUTER; HAD CONSTANT DRY EYE, CAUSING PAIN AND IRRITATION. ALSO HAD INTERMITTENT CLOUD-LIKE FILM. THE LENS REMAINED IMPLANTED. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2024-01675.

  Patient problems: Iritis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217888 ↗
• InjuryApr 3, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -10.50/3.0/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. THE SURGEON REPORTS THAT THE LENS IS RUBBING AGAINST THE PATIENT'S IRIS. THE LENS WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038651 ↗
• InjuryOct 30, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, VTICM5_13.2, -10.50/+3.5/135 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT, LIGHT ANISOCORIA/BLURRY VISION. THIS EXCHANGED RESOLVED THE PROBLEM. CAUSE OF THIS EVENT WAS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18036112 ↗
• MalfunctionApr 25, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.5/+3.0/092 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. WITHIN THE INITIAL SURGERY THE LENS WAS REMOVED AND REPLACED INTRA-OPERATIVELY FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811559 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-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.