EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-13.5/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311311811), received between Jun 7, 2023 and Dec 11, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULT. LENS REMAINS IMPLANTED. REPORTER STATED IOP CONTROLLED BY MEDICATION. CAUSE OF THE EVENT IS UNKOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 20908746 ↗
• InjuryMar 5, 2024Inadequacy 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 -13.5/2.0/95 (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. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842905 ↗
• InjuryMar 1, 2024Inadequacy 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 IMPLANTABLE COLLAMER LENS OF DIOPTER -13.50/2.0/095 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) 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 18823044 ↗
• InjuryAug 31, 2023Patient-Device Incompatibility; Device Dislodged or Dislocated; Patient-Device Incompatibility; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -13.50/2.0/027 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. LENS DISLOCATION AND SUBLUXATION WAS OBSERVED. ON (B)(6) 2023, THE LENS WAS REPOSITIONED. LENS REPOSITIONING DID NOT RESOLVE THE PROBLEM. CAUSE OF THE EVENT WAS A PATIENT RELATED FACTOR. THE DEVICE DID NOT PERFORM AS INTENDED. REPORTEDLY, "ICL MOVED FROM CENTRAL AREA TO THE INFERIOR PART OF THE EYE." THE PROBLEM WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665002 ↗
• InjuryJun 7, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -13.5/2.0/092 WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023 AS A REPLACEMENT LENS TO ADDRESS LOW VAULT BUT THE VAULT DID NOT RESOLVE. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS UNKNOWN. SEE MFR # 2023826-2023-02264 FOR CLAIM AGAINST THE INITIAL LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083202 ↗

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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• 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.