EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.5) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00840311300617), received between Nov 22, 2022 and Aug 30, 2026 — classified as 23 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (7 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision

  MAUDE report 50513214 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED OVER/UNDER CORRECTION. THE LENS WAS EXCHANGED FOR A SAME MODEL, POWER AND LENGTH LENS. THE PROBLEM WAS RESOLVED. 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.

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

  MAUDE report 25610329 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED PIGMENT DISPERSION AND A CATARACT DEVELOPED. THE LENS REMAINS IMPLANTED. REPORTEDLY, 'PATIENT IS SCHEDULED TO HAVE CATARACT SURGERY WHERE THE ICL WILL THEN BE EXPLANTED'. THE CAUSE OF THE EVENT IS OTHER. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 25007071 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED OVER/UNDER CORRECTION. THE LENS WAS EXCHANGED FOR A DIFFERENT POWER LENS OF A SHORTER LENGTH AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 24389905 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) REPLACEMENT LENS PROCEDURE. REFRACTIVE TREATMENT OF LRI WAS ALSO PERFORMED. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369404 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS (ICL) WAS IMPLANTED UPSIDE DOWN. THE LENS WAS REMOVED AND REPLACED. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339176 ↗
• InjuryJan 7, 2026Adverse 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 SHALLOWING OF THE AC, AND GLARES AND HALOES. THE LENS WAS LATER EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS OTHER. 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: Halo; Visual Disturbances

  MAUDE report 23993142 ↗
• InjuryJan 7, 2026Adverse 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 SHALLOWING OF THE AC, AND GLARES AND HALOES. THE LENS WAS LATER EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS OTHER. 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: Halo; Visual Disturbances

  MAUDE report 23993135 ↗
• InjuryNov 14, 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 AN OVER/UNDER CORRECTION & COMPLAINED OF FAR VISION. THE LENS WAS EXCHANGED FOR A LENS OF A DIFFERENT POWER & THE PROBLEM WAS RESOLVED.

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

  MAUDE report 23560957 ↗
• InjuryNov 7, 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 AN ASTIGMATISM. AN LRI WAS PERFORMED AND THE PROBLEM WAS RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501016 ↗
• InjuryDec 10, 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 LOW VAULT. DUE TO THE LOW VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20896485 ↗
• InjuryOct 2, 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 LOW VAULT. THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENGTH LENS 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. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355161 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACULTY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT. DUE TO LOW VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089282 ↗
• InjuryJul 12, 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 LOW VAULT. DUE TO LOW VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A LONGER LENGTH LENS. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729598 ↗
• MalfunctionMay 1, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.50 TORE/BROKE BEFORE/DURING LOADING ON (B)(6) 2024. THE DAMAGE OCCURRED DURING LOADING. THERE WAS NO PATIENT CONTACT. THE LENS WAS NOT IMPLANTED. ON THE SAME DAY SEPARATE SURGERY A REPLACEMENT LENS OF THE SAME PARAMETERS WAS IMPLANTED INTO THE RIGHT EYE (OD) AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226748 ↗
• MalfunctionApr 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6 VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER LENS TEAR/BREAK DURING LOADING . THE LENS WAS NOT IMPLANTED INTO THE PATIENTS RIGHT EYE (OD). ON (B)(6) 2024 A REPLACEMENT WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217477 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON (B)(6) 2024, THE LENS WAS EXCHANGED FOR A SAME SIZE, DIFFERENT POWER LENS DUE TO REFRACTIVE SURPRISE. CAUSE OF THE EVENT IS UNKNOWN. STATUS OF THE EYE IS "CORRECT." THE PROBLEM WAS RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 19185405 ↗
• InjuryApr 18, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICM5_12.6; -10.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REPORTED AS EXCESSIVE VAULTING. ON (B)(6) 2024 THE LENS WAS EXPLANTED. LATER THAT DAY IT WAS REPLACED WITH A SHORTER LENGTH LENS. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139247 ↗
• MalfunctionApr 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM, VICM5_12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED AND REMOVED FROM THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. BACK UP LENS WAS IMPLANTED ON (B)(6) 2024 DUE TO PATIENT MOVEMENT DURING IMPLANTATION CAUSING LENS TO STICK IN INCISION AND CORNEA SCRATCH DURING REMOVAL OF LENS. THIS RESOLVED THE PROBLEM. PATIENT RELATED FACTOR: PATIENT MOVEMENT DURING IMPLANTATION. LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061156 ↗
• MalfunctionMar 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6. -10.5 DIOPTER IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. THERE WAS NO PATIENT CONTACT(LENS DID NOT TOUCH THE EYE). BACK-UP LENS IMPLANTED AND PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922748 ↗
• MalfunctionJan 9, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5 12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS FROM THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. LOW VAULT WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473811 ↗
• InjuryNov 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS -10.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT. ON (B)(6) 2023 A REPLACEMENT LENS OF SHORTER LENGTH WAS IMPLANTED. IT WAS REPORTED THAT THE PROBLEM RESOLVED, "STABLE WITH LOW VAULT" WAS REPORTD. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243676 ↗
• InjuryOct 3, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Off-Label Use; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS DUE TO LOW VAULT ON (B)(6) 2023. THIS DID NOT RESOLVE THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR, LENS TOO SHORT. REPORTEDLY, PATIENT STATES NEAR VISION NOT SO CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862040 ↗
• InjurySep 26, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, PUPIL BLOCK WITH ELEVATED INTRAOCULAR PRESSURE AND UNREACTIVE (FIXED) PUPIL. CAUSE OF EVENT WAS REPORTED AS "DEVICE". 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; Pupillary Block

  MAUDE report 17822369 ↗
• InjurySep 18, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6, -10.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE SURGEON REPORTS THERE WAS LENS ROTATION, HALOS, STARBURST, DIPLOPIA, THE LENS WAS REPOSITIONED ON (B)(6) 2023 THE LENS WAS REPOSITIONED BUT THIS DID NOT RESOLVE THE PROBLEM. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED AND IT WAS NOTED "VAULT IS HIGHER BUT OK, LENS IS CENTERED". THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR WITH NO DEVICE CAUSALITY AND NOTED "DESCENTRATION CAUSED SHORT LENGTH".

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

  MAUDE report 17770483 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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.