EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-10.0/1.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840311311460), received between Dec 22, 2022 and Apr 13, 2026 — 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.

• InjuryApr 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 DIFFERENT MODEL LENS. PROBLEM 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 REPORTED AS USER ERROR.

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

  MAUDE report 24864917 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  BLURRED VISION. CLOUDY VISION. PAIN. PRESSURE IN THE EYE. COULD NOT KEEP IT OPEN. VISION WAS POOR. MEDICAL MANAGEMENT. LENS REMAINS IMPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 24846415 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LENS ROTATION. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM, THE LENS WAS LATER EXCHANGED, AND THE PROBLEM WAS RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795868 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT PRIOR AN IMPLANTABLE COLLAMER LENS (ICL) PROCEDURE, THE LENS TOO BIG FOR THE EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, IRIS ATROPHY AND IRIS PROLAPSE. THE LENS WAS REPOSITIONED AND EXPLANTED, THE REPLACEMENT LENS OF A SHORTER LENGTH IMPLANTED. CAUSE WAS REPORTED DUE TO SIZING ERROR DESPITE FOLLOWING NOMOGRAMS.

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

  MAUDE report 21028799 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE CRYSTALLINE LENS HAD BECOME OPACIFIED (CATARACT ASC). THE SURGEON EXPLANTED THE LENS.

  Patient problems: Cataract

  MAUDE report 20859370 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A TORIC EVO ICL IMPLANTABLE COLLAMER LENS, INTO THE PATIENTS EYE. AT ONE MONTH POST-OP, THE PATIENT HAD PERSISTENT ELEVATED INTRAOCULAR PRESSURE (IOP), WHICH WAS BEING TREATED WITH IOP LOWERING MEDICATIONS. THE PATIENT HAD NO SYMPTOMS OF ANGLE CLOSURE AND NO SIGNS OF INFLAMMATION. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 18287965 ↗
• InjuryNov 14, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.00/+1.5/100, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 18136617 ↗
• InjuryJun 5, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -10.0/1.5/81 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. LOW VAULT WITHOUT ROTATON WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057153 ↗
• InjuryDec 22, 2022Inadequacy 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, -10.0/1.5/002 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO EXCESSIVE VAULT. IN A SECOND SURGERY ON (B)(6) 2022 A SHORTER LENGTH LENS WAS IMPLANTED. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

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

  MAUDE report 16035460 ↗

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-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.
• 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.
• 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.