EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.5/3.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311309016), received between May 8, 2023 and Jul 13, 2026 — classified as 4 injuries, 2 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 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. THE LENS WAS EXCHANGED WITH A DIFFERENT DIOPTER LENS AND 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 25798690 ↗
• InjuryAug 12, 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 ANTERIOR SUBCAPSULAR CATARACT, GLARES, AND HALOES. THE LENS REMAINS IMPLANTED. THE CAUSE OF EVENT WAS REPORTED AS USER ERROR, "DURING THE SURGERY THERE WAS CATARACT WITH THE LENS RESULTING THE SMALL ANTERIOR SUBCAPSULAR CATARACT."

  Patient problems: Cataract; Halo; Visual Disturbances

  MAUDE report 22786184 ↗
• InjuryDec 28, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -13.50/3.0/102 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 LENS REPOSITIONING WAS PERFORMED DUE TO LOW VAULT WITH ROTATION BUT THE PROBLEM DID NOT RESOLVE. ON (B)(6) 2023 THE LENS WAS REMOVED AND A REPLACEMENT LENS OF LONGER LENGTH WAS LATER IMPLANTED AND THE PROBLEM RESOLVED. IN THE REPORTER OPINION THE CAUSE OF THE EVENT WAS THE DEVICE "ICL TOO SHORT DESPITE SIZING RECOMMENDATION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18413877 ↗
• MalfunctionMay 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -13.50/+3.0/104 (SPHERE/CYLINDER/AXIS), TORE DURING INJECTION. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976426 ↗
• MalfunctionMay 8, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT WHILE ATTEMPTING TO LOAD A 12.6MM VTICM5_12.6; -13.50/3.0/095 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS ON (B)(6) 2022, THE LENS HAD TORE. IT WAS INDICATED THE LENS TORE WHILE PULLING THE LENS WITH THE FORCEPS. THE LENS WAS NOT IMPLANTED. ON (B)(6) 2023 A REPLACEMENT LENS OF THE SAME MODEL/LENGTH WAS IMPLANTED BUT THIS DID NOT RESOLVE THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE; AND THE DEVICE DID FAIL TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891775 ↗
• InjuryMay 8, 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; -13.50/3.0/114 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON REPORTS PRODUCT NON CONFORMITY AND NOTED "LENS CAME OUT WITH VERY LOW VAULT", PATIENT HAD LOW VAULTING AND ON (B)(6) 2023 THE LENS WAS EXPLANTED. ON THIS SAME DATE IN A SEPARATE SURGERY A REPLACEMENT LENS OF LONGER LENGTH WAS IMPLANTED. IT WAS ALSO INDICATED THERE WAS AN INCISION ENLARGEMENT AND AN ADDITIONAL SUTURE WAS REQUIRED. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND THE DEVICE DID FAIL TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891774 ↗

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-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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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.