EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-3.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311300792), received between Apr 15, 2023 and Jun 24, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Misfocusing” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED POOR VISUAL OUTCOME. THE LENS WAS LATER EXCHANGED FOR A SAME SIZE, DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS OTHER.

  Patient problems: Blurred Vision

  MAUDE report 25615891 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED OVER/ UNDER CORRECTION. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25551874 ↗
• InjuryFeb 26, 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 AND PERIPHERAL SHADOWING. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 24457298 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS OF UNKNOWN MODEL AND SIZE INTO THE PATIENT'S LEFT EYE (OS) ON AN UNKNOWN DATE. REPORTEDLY, "UNEXPECTED DIFFUSED CORNEA ENDOTHELIAL FAILURE IN A QUIET NON TRAUMATIC UNEVENTFUL LEFT EYE ICL SURGERY. WILL CONTINUE TO MONITOR THE EYE." TO THE BEST OF OUR KNOWLEDGE THE LENS REMAINS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19072902 ↗
• InjuryNov 28, 2023Adverse 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 VICM5_13.2; -3.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT HAD LENS OPACITY, ASC/NS WHICH WAS OBSERVED ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS EXPLANTED AND CATARACT WITH A POSTERIOR CHAMBER LENS WAS PERFORMED WAS ADDITIONALLY REPORTED.

  Patient problems: Cataract

  MAUDE report 18223150 ↗
• InjuryJun 16, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -3.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. THE PATIENT EXPERIENCED REFRACTIVE CHANGE OVER TIME. ON (B)(6)2023 THE LENS WAS EXPLANTED AND LATER ON THIS DATE REPLACED WITH A SAME LENGTH BUT DIFFERENT POWER LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 17148654 ↗
• InjuryApr 15, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -3.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO HALO AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN. FOR CAUSE DETAILS THE REPORTER INDICATED "THE PATIENT WAS NOT COMFORTABLE WITH HIS VISION".

  Patient problems: Halo

  MAUDE report 16748577 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.