EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-12.5/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542116923), received between Jan 10, 2023 and Mar 24, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HIGH VAULT. PATIENT NEEDED TO BE MED. LENS REMAINS IMPLANTED. CAUSE OF EVENT WAS NOT REPORTED.

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

  MAUDE report 21678204 ↗
• InjuryOct 13, 2023Device Dislodged or Dislocated; Optical Problem; Device Dislodged or Dislocated; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM TMICL13.2; -12.5/+1.00/179 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. THE PATIENT EXPERIENCED LENS ROTATION, THE SURGEON ALSO NOTED HEADACHES, CORNEAL EDEMA, BLURRY VISION AND GLARES. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS USER ERROR - PREOP AXIS WAS NOT ACCURATE BASED ON THE TOPOGRAPHY AND AUTO-REFRACT AXIS OF ABOUT 49 DEGREES AND IT WAS A PRE-OP MEASUREMENT ERROR NOT AN ISSUE WITH THE LENS ITSELF.

  Patient problems: Blurred Vision; Corneal Edema; Eye Pain; Headache

  MAUDE report 17935878 ↗
• MalfunctionMay 18, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.50/1.0/035 (SPHERE/CYLINDER/AXIS), TORE DURING LOADING AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT IS DOING WELL AND HAPPY WITH VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957512 ↗
• MalfunctionJan 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.50/+1.0/087 (SPHERE/CYLINDER/AXIS), INTO PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE HAPTIC WAS STUCK BY THE FOAM TIP PLUNGER TIP UPON INSERTION AND A SMALL PIECE WAS RIPPED. THE LENS REMAINED IMPLANTED WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129942 ↗
• MalfunctionJan 10, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.50/+1.0/086 (SPHERE/CYLINDER/AXIS), WITHIN THE SAME SURGERY DUE TO THE LENS WAS INSERTED UPSIDE DOWN WHEN INJECTED INTO THE PATIENTS LEFT EYE (OS). THE LENS WAS TORN UPON REMOVAL AND WAS DISCARDED. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129918 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-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-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.