EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-7.5/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840311308330), received between May 30, 2023 and Jul 28, 2026 — classified as 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced lens rotation. The lens was repositioned, but repositioning did not resolve the problem. The lens was later exchanged for a longer length lens and the problem was resolved. Cause of the event is unknown.

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

  MAUDE report 50048434 ↗
• InjuryFeb 17, 2026Adverse 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 AND REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED. THE PATIENT UNDERWENT A PHACOEMULSIFICATION AND CATARACT SURGERY. AN IOL INSERTION PERFORMED. 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: Blurred Vision

  MAUDE report 24370231 ↗
• InjuryJul 4, 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 LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. DUE TO LENS ROTATION NOT ASSOCIATED TO LOW VAULT, THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 22403694 ↗
• InjuryMay 15, 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 LOW VAULT WITH LENS ROTATION AND BLURRED VISION. IN A SEPARATE SURGERY THE LENS WAS EXPLANTED. ON THE SAME DAY SEPARATE SURGERY, A LONGER LENGTH LENS WAS IMPLANTED, AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER. CAUSE DETAILS PROVIDED: "LOW VAULT". THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 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: Blurred Vision

  MAUDE report 22031368 ↗
• InjuryAug 13, 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 REFRACTIVE SURPRISE. THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY WITH A DIFFERENT DIOPTER LENS AND 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. CAUSE OF THE EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972785 ↗
• InjuryJul 17, 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 A LOW VAULT. ON A DIFFERENT DAY THE LENS WAS EXCHANGED WITH THE SAME MODEL, LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763696 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -07.50/+2.0/011 (SPHERE/CYLINDER/AXIS) IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS REMOVED ON (B)(6) 2024 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18975690 ↗
• MalfunctionMar 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -7.50/2.00/90 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. INTRAOPERATIVELY THE LENS WAS REMOVED. ON (B)(6) 2023 A REPLACEMENT LENS OF THE SAME LENGTH BUT DIFFERENT AXIS WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR WITH DEVICE CAUSALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871115 ↗
• InjuryDec 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF A -7.5/2.0/092 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED AND A LARGER LENGTH LENS WAS IMPLANTED DUE TO A LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE EYE. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415867 ↗
• InjurySep 26, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.5/2.0/094 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT WITH ROTATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822287 ↗
• InjuryMay 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.5/+2.0/095 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM. CAUSE REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027934 ↗

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