EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.6 (-14.5/3.0) (REF VTICMO 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00840311323838), received between Jun 20, 2023 and Jun 3, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A LONGER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25384610 ↗
• InjuryDec 27, 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 BLURRED VISION AND LENS ROTATION/ REPOSITIONING. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A SPHERICAL MODEL, SAME LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE.

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

  MAUDE report 23903166 ↗
• 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 LOW VAULT WITH ROTATION. IN A SEPARATE VISIT THE LENS WAS REPOSITIONED. IN A THIRD VISIT THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. IT WAS NOTED THAT THE REPLACEMENT LENS WAS IMPLANTED VERTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751967 ↗
• InjuryNov 22, 2024Adverse 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 GLARE/HALOS. DUE TO GLARE/HALOS, LENS WAS REMOVED. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN. THERE ARE MULTIPLE 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: Halo; Visual Disturbances

  MAUDE report 20759114 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. AT A LATER DATE, THE LENS WAS REMOVED AND EXCHANGED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591813 ↗
• MalfunctionOct 28, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED POOR VISUAL QUALITY AND BLURRED VISION. THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 20547965 ↗
• InjuryOct 15, 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 EXPERIENCED EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS OF DIFFERENT POWER AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTS AS UNKNOWN. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456040 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS ONE OF FIVE THAT ARE REPORTING THE SAME ISSUE OF POTENTIAL TASS OBSERVED ONLY IN ONE CASE BUT COULD NOT BE SEPARATED DUE TO LACK OF ADDITIONAL INFORMATION. THE REPORTER INDICATED THAT THE SURGEON IMPLANTED 12.6MM VTICMO 12.6 OF DIOPTER -14.50/3.0/071 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S EYE DURING THE WEEK OF (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE THE LIOLI-24 INJECTOR AND OCUCOAT OVD. ONE CASE WAS ASSESSED AS POTENTIAL TASS BUT WAS NOT SPECIFIED BY RECEIVED SERIAL NUMBERS OF 5 LENSES. IN ALL CASES INTRAOPERATIVELY THE ICL LOOKED LIKE THERE WERE DEPOSITS ON IT AND AT THE SAME DAY POST-OP CHECK ICL LOOKED LIKE IT HAD STREAKS ON IT. IN ONE CASE THERE WAS AN OBSERVATION OF" ALMOST GLITTERY APPEARANCE WITH SOME DEPOSITS ON THE ANTERIOR CRYSTALLINE CAPSULES". REPORTEDLY, DEPOSITS/STREAKS HAVE DISAPPEARED ON THEIR OWN WITHIN 24 HOURS. NO ABNORMALITIES WERE NOTED WITH THE ICL VIAL PRIOR TO LENS IMPLANTATION. TWO SURGEONS FROM THE SAME CLINIC HAD A "COUPLE OF ICL CASES" OF SIMILAR PRESENTATION WITHIN THE SAME THAT WEEK AND ONE OF THEM HAD OBSERVATIONS FOR CARTRIDGES "FEEL A BIT TIGHTER" AS WELL AS THAT OCUCOAT CANNULAS LOOK LIKE" THEY HAVE SOME

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20163964 ↗
• InjuryMar 5, 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 VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.5/3.0/090 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT WITHOUT ROTATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842630 ↗
• MalfunctionDec 15, 2023Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -14.50/+3.0/091 (SPHERE/CYLINDER/AXIS), TORE/BROKE BEFORE LOADING, AFTER OPENING THE VIAL. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337565 ↗
• InjuryDec 15, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.5/+3.0/088 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT AND LENS ROTATION. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336979 ↗
• InjuryOct 26, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICMO 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.5/3.0/093 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO LOW VAULT WITHOUT ROTATION. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18017065 ↗
• InjurySep 8, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICMO12.6 IMPLANTABLE COLLAMER LENS, -14.50/+3.0/107 (SPHERE/CYLINDER/AXIS), IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO PATIENT COMPLAINED OF GLARE/HALOES, DIZZINESS, NAUSEA, EYE FATIGUE AND PAIN. THE PROBLEM WAS RESOLVED. THE INTRAOCULAR PRESSURE WAS NORMAL AND GOOD NEAR AND FAR VISION.

  Patient problems: Dizziness; Eye Pain; Fatigue; Halo; Nausea; Visual Disturbances

  MAUDE report 17715562 ↗
• InjuryJun 20, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM, VTICMO12.6, -14.5/3.0/086 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. LOW VAULT WITH ROTATION WAS OBSERVED, THE LENS WAS REPOSITIONED ON (B)(6) 2023, BUT DID NOT RESOLVE THE PROBLEM. LENS REMAIN IMPLANTED. CAUSE OF THE EVENT IS REPORTED AS OTHER, DEVICE DID NOT FAIL TO PERFORM AS INTENDED, SMALL SIZE LENS WITH ROTATION AND CHANGING ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163482 ↗

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-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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.