EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-12.0/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542115254), received between Mar 15, 2023 and Jun 21, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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.

• InjuryJun 21, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED AN UNKNOWN MODEL ICL INTO THE PATIENT'S EYE. REPORTEDLY, THE LENS WAS TOO SMALL. THE LENS WAS LATER REPLACED WITH A LONGER LENGTH LENS. NO POST EXCHANGE DATA WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19587242 ↗
• InjuryOct 18, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Off-Label Use; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -12.00/+1.5/089 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD). THE LENS HAD EXCESSIVE VAULTING AND SHALLOW AC. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962098 ↗
• InjuryAug 3, 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 -12.00/1.5/094 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS REMOVED DUE TO HIGH VAULT CAUSING PAIN AND HIGH PRESSURE. A REPLACEMENT LENS OF SHORTER LENGTH WAS LATER IMPLANTED ON THE SAME DATE AND THE PROBLEM RESOLVED.

  Patient problems: Eye Pain; Intraocular Pressure Increased

  MAUDE report 17454729 ↗
• InjuryJun 15, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -12.00/+1.5/024 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS EYE ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023. THE LENS WAS REPLACED WITH A LONGER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138047 ↗
• InjuryMar 15, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -12.00/+1.5/093 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS). THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO AN OVERSIZED LENS. THE LENS WAS REPLACED WITH A SHORTER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545492 ↗

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-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.
• 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-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.