EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-9.5/2.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311308378), received between May 26, 2023 and Sep 28, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50917668 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT HAD WRONG SIZE LENS IMPLANTED. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 20131667 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS (ICL) FLIPPED AND COULD NOT BE FLIPPED BACK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757243 ↗
• MalfunctionFeb 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.50/+2.0/069 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2024. THE LENS TORE, BROKE DURING INJECTION DELIVERY INTO THE EYE AND THERE WAS NO PATIENT INJURY. THE LENS REMAINED IMPLANTED. THE CAUSE OF THE EVENT WAS DUE TO USER ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18680629 ↗
• InjuryFeb 1, 2024Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -9.5/2.0/071 WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2024 THE LENS WAS EXPLANTED DUE TO ELEVATED IOP; BLURRED VISION AND PIGMENT IN ANTERIOR CHAMBER BEING OBSERVED. IT WAS NOTED THAT NO HISTORY OF PIGMENT DISPERSION AND GONIOSCOPY NORMAL PRE-OP.

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

  MAUDE report 18620294 ↗
• MalfunctionDec 19, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -9.50/2.0/101 (SPHERE/CYLINDER/AXIS) TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENTS EYE. THE LENS WAS IMPLANTED,REMOVED AND REPLACED INTRAOPERATIVELY WITH NO PATIENT INJURY AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18353471 ↗
• MalfunctionNov 20, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6, -9.5/2.0/094 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. LOW VAUT WAS OBSERVED. THE LENS REMAINS IMPLANTED. REPORTEDLY: PATIENT IS SUPER HAPPY. PATIENT WILL BE MONITORED AND NO EXCHANGE IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18174982 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.50/+3.0/102 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO PATIENT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE (IOP) AND PIGMENT DISPERSION. PATIENT DEVELOPED CHRONIC INFLAMMATION WITH HIGH IOP. MEDICATION WAS ADMINISTERED - ANTIGLAUCOMA; COMBIGAN; AZOPT; XALATAN. POST-OP, THE ANTERIOR CHAMBER HAD MILD INFLAMMATION WITH PIGMENT CELL. THE PATIENT STILL CONTINUES WITH 2 TYPES OF ANTIGLAUCOMA - TIMOLOL BD AND AZOPT BD. CAUSE OF THE EVENT WAS UNKNOWN.

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

  MAUDE report 17741439 ↗
• MalfunctionAug 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2023 A 12.6MM VTICM5_12.6, -9.5/2.0/090, IMPLANTABLE COLLAMER LENS GOT STUCK IN THE CARTRIDGE AND TORE, THERE WAS PATIENT CONTACT. THE LENS WAS INTRAOPERATIVELY REMOVED WITH NO PATIENT INJURY. ON (B)(6) 2023 A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628423 ↗
• MalfunctionMay 26, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS WITH DIOPTER -9.50/+2.0/091 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. WITHIN THE INITIAL SURGERY THE LENS WAS REMOVED AND REPLACED WITH A LONGER LENGTH LENS DUE TO LOW VAULT. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015321 ↗

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-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-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-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.