EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-13.0/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542116992), received between Jun 29, 2022 and Apr 1, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 29, 2023Class IIOpen, Classified

   Their is a potential that intraocular implant devices may not meet specifications.

   Z-0472-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -13.0/1.0/086 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. REPORTEDLY, "LENS TO BE EXPLANTED BECAUSE IT IS TOO BIG, WILL REPLACE WITH A SHORTER LENGTH." TO THE BEST OF OUR KNOWLEDGE THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013326 ↗
• InjuryJun 30, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -13.0/1.0/115 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, GLARE/HALOES AND BLURRED VISION. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND ON THIS SAME DATE IN A SEPARATE SURGERY THE LENS WAS REPLACED WITH A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND NOTED "SIZE 13.2 TOO LARGE".

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

  MAUDE report 17239641 ↗
• InjuryDec 16, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS OF UNKNOWN MODEL AND SIZE WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON AN UNKNOWN DATE. ELEVATED IOP AND NARROW ANGLES WERE REPORTED. THE LENS REMAINS IMPLANTED AND THE PATIENT DOES NOT WANT THE LENS TO BE REMOVED. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 16000874 ↗
• InjuryJun 29, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF -13.0/1.0/105 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). ON (B)(6) 2022 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE EXCHANGE RESOLVED THE PROBLEM. CAUSE IS PATIENT RELATED-FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861997 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-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.