EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-15.5/1.5) (REF VTICMO 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840311322770), received between Apr 25, 2023 and Sep 20, 2024 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 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. DUE TO LOW VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR ANOTHER SAME MODEL/LENGTH BUT DIFFERENT POWER LENS. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271799 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION INTO THE PATIENT'S EYE. THE LENS WAS EXCHANGED FOR A SAME MODEL AND SIZE BUT DIFFERENT POWER LENS DUE TO OPERATOR ERROR IN SELECTING ICL. THE PROBLEM WAS RESOLVED. THE CAUSE WAS REPORTED AS USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20259909 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED FRACTIVE SURPRISE THE LENS WAS REPLACED, AND THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS THE 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. IN ADDITION, IT HAS BEEN NOTED THAT THE SURGEON SELECTED A SHORTER LENS THAN THAT INITIALLY SUGGESTED BY OCOS. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY.

  Patient problems: Blurred Vision

  MAUDE report 19989164 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF -15.5/1.5/110 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS EXCHANGED FOR A SAME SIZE MODEL LENS DIFFERENT SPHERE/CYCLINDER/AXIS DUE TO REFRACTIVE SURPRISE AND REFRACTIVE CHANGE OVERTIME. THE PROBLEM RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18984061 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -15.5/1.5/085 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A SAME SIZE , DIFFERENT DIOPTER LENS DUE TO REFRACTIVE SURPRISE. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18979477 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -15.5/1.5/085 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2024, THE LENS WAS REPLACED WITH A SAME SIZE , DIFFERENT DIOPTER LENS DUE TO REFRACTIVE SURPRISE. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18979469 ↗
• InjuryDec 22, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -15.50/+1.5/067 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO PATIENT WAS EXPERIENCING ORBITAL PAIN DUE TO PSYCHOLOGICAL EFFECTS AND THE PROBLEM WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Eye Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18389058 ↗
• InjuryJul 11, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -15.5/1.5/091 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302553 ↗
• InjuryApr 25, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -15.50/+1.5/109 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD LOW VAULTING AND REMAINED IMPLANTED. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811652 ↗

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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.