EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-7.5/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00840311308057), received between Dec 7, 2022 and Sep 23, 2026 — classified as 12 injuries, 2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 50874314 ↗
• InjuryDec 8, 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 EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES AND SIGNIFICANT SHALLOWING OF AC. IN A SEPARATE SURGERY, THE LENS WAS EXCHANGED WITH A SHORTER LENGTH AND THE PROBLEM WAS RESOLVED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

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

  MAUDE report 23750718 ↗
• InjuryDec 8, 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 A CORNEAL EDEMA AND A LOW VAULT. THE LENS REMAINS IMPLANTED. MEDICATION WAS PRESCRIBED, "MURO 128". REPORTEDLY, "CLEARED UP". THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Corneal Edema

  MAUDE report 23744831 ↗
• InjurySep 5, 2025Adverse 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 EXPERIENCED A LENS ROTATION WITH GLARE/HALOES, AND BLURRED VISION. THE LENS WAS REPOSITIONED AND THEN EXCHANGED FOR A LONGER LENGTH LENS & THE PROBLEM RESOLVED. CAUSE OF THE EVENT LISTED AS OTHER, "UNDERSIZED OVER-ROTATED TORIC."

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22987060 ↗
• InjuryMar 12, 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 A LOW VAULT WITH ROTATION AND BLURRED VISION. THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS REPORTED AS OTHER. LENS ROTATION AND SECONDARY SURGICAL INTERVENTION TO REMOVE/REPLACE/REPOSITION THE LENS IS AN EXPECTED OR FORESEEABLE SIDE EFFECT.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21589810 ↗
• InjuryJan 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 EXCESSIVE VAULT. REPORTEDLY, "ANTERIOR CHAMBER ALMOST GONE IN HIGH VAULT, GLAUCOMATOUS ATTACK, ATTEMPTED TO CONSTRICT WITH OBISORT BUT NOT POSSIBLE." THE LENS WAS LATER REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21233653 ↗
• MalfunctionMay 10, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -07.50/+1.5/069 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2024. THE LENS WAS REPORTED AS HAVING LOW VAULTING AND THE SURGEON HAS DECIDED TO LEAVE THE LENS IN THE EYE. PATIENT WILL RETURN FOR FOLLOW-UP VISIT IN 5 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19292035 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF A -7.5/1.5/092 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE. CONCOMITANT PRODUCT INFORMATION USED INTRAOPERATIVELY INCLUDING VISCOELASTIC AND DELIVERY SYSTEM TYPE WERE NOT PROVIDED. ON (B)(6) 2024, DAY 1, TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. PUPIL FIBRIN WAS OBSERVED. ANTIBIOTIC AND STEROID OPHTHALMIC DROPS AS WELL AS ORAL STEROIDS WERE PRESCRIBED. VISUAL ACUITY WAS NOTED AS OF (B)(6) 2024 TO BE IMPROVED FROM 1.2 (~20/15) TO 1.5 (~20/12). THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19102333 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -7.50/1.5/095 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH DUE TO EXCESSIVE VAULT. THE REPLACEMENT LENS RESOLVED THE PROBLEM. CAUSE OF THIS EVENT WAS REPORTED AS A PATIENT RELATED FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047929 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.50/1.5/091 INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. LOW VAULT WITH ROTATION WAS OBSERVED. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS AND PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18848790 ↗
• InjuryFeb 8, 2024Inadequacy 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, -07.50/+1.5/049 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO LOW VAULTING. THE LENS WAS REPLACED WITH A LONGER LENS BUT THE PROBLEM WAS NOT RESOLVED. SEE MFR. REPORT # 2023826-2024-00279 FOR REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670923 ↗
• InjuryNov 6, 2023Misfocusing; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Misfocusing; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -7.5/1.5/122 (SPHERE/CYLINDER/AXIS) LENS TORE DURING INJECTION/DELIVERY INTO THE RIGHT EYE (OD) OF A PATIENT WITH PRE-EXISTING PROGRESSIVE MYOPIA, ON (B)(6) 2023. LENS DISLOCATION/SUBLUXATION AND DOUBLE VISION ARE OBSERVED. CAUSE OF THE EVENT IS UNKNOWN. REPORTEDLY, "HAPTICS CUT." THE PROBLEM IS NOT RESOLVED.

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

  MAUDE report 18080354 ↗
• InjuryMar 8, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -7.50/1.50/29 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE SURGEON REPORTS THERE WAS A REFRACTIVE ERROR DUE TO WRONG LENS CALCULATION; AXIS 117 INSTEAD OF 177 WAS USED. ON (B)(6) 2023 THE LENS WAS EXPLANTED. ON THIS SAME DATE IN A SEPARATE SURGERY A REPLACEMENT LENS OF THE SAME LENGTH BUT DIFFERENT POWER WAS IMPLANTED AND THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS USER ERROR.

  Patient problems: Blurred Vision

  MAUDE report 16507974 ↗
• MalfunctionDec 7, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 -7.5/1.5/073 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS' LEFT EYE (OS) ON (B)(6) 2022 AS A REPLACEMENT LENS TO ADDRESS EXCESSIVE VAULT BUT IT DID NOT RESOLVE THE PROBLEM. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929758 ↗

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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.