EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-4.0/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311311064), received between Mar 16, 2023 and Aug 7, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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.

• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED A 13.2MM VTICM5 -4.00/+1.00/171 WAS IMPLANTED ON (B)(6) 2023. AFTER THE PROCEDURE, MORE THAN A YEAR LATER, THE EXCESSIVE VAULT OF ICL WAS OBSERVED WITH CELLS IN THE ANTERIOR CHAMBER ("NOT APPEAR TO BE PIGMENTATION") AND "ICL DEPOSIT". ENDOPHTHALMITIS WAS DIAGNOSED AND THE LENS WAS EXPLANTED ON (B)(6) 2024. DIAGNOSTIC TESTS WERE PERFORMED AND BOTH CULTURE AND PATHOLOGY RESULTS WERE NON-INFECTIOUS. TREATMENT WITH STEROIDS WAS PRESCRIBED. ON 12-JUL-2024, THE LAST REPORT STATED A BCVA 20/33 AND THE ISSUE RESOLVED. THE REPORTER STATES THE CAUSE OF THE EVENT WAS UNKNOWN. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY 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: Endophthalmitis

  MAUDE report 19931388 ↗
• InjuryJun 5, 2024Adverse 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 VTICM5_13.2; -4.00/+1.0/150 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. ON (B)(6) 2024 THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473854 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -4.0/1.0/090 (SPHERE/CYLINDER/AXIS), WAS IMPLANTED INTO THE RIGHT EYE (OD) OF A PATIENT WITH SUSPECTED KERATOCONUS ON (B)(6) 2024. ON (B)(6) 2024, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT, ELEVATED IOP, AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. CAUSE OF THE EVENT IS UNKNOWN. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19185390 ↗
• InjuryFeb 16, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -4.0/1.0/133 (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 SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES.THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS A REPORTED AS THE DEVICE. STATUS OF THE EYE IS REPORTED AS NORMAL WITHOUT SIGNS AND SYMPTOMS.

  Patient problems: Halo; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723041 ↗
• InjuryDec 22, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -04.00/+1.0/001 (SPHERE/CYLINDER/AXIS) IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE EYE IS CALM. THE CAUSE OF THE EVENT WAS DUE TO PROBABLE IRREGULAR EYE; SMALL ANGLE-TO-ANGLE.

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

  MAUDE report 18387576 ↗
• InjuryMar 16, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -04.00/+1.0/087 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO EXCESSIVE VAULTING, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, GLARE/HALOES AND BLURRED VISION. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 16555053 ↗

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