EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-10.5) (REF VICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840311300280), received between Dec 16, 2022 and Mar 31, 2026 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING A REPLACEMENT IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ASTIGMATISM. DUE TO ASTIGMATISM, LASEK WAS PERFORMED. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

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

  MAUDE report 24749997 ↗
• 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 HEADACHES & DISCOMFORT. THE LENS WAS EXPLANTED. CAUSE OF THE EVENT LISTED AS PATIENT RELATED FACTOR. 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: Discomfort

  MAUDE report 23560961 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICM5_ 12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.5 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A SAME LENGTH/DIFFERENT MODEL LENS DUE TO REFRACTIVE SURPRISE. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 19580571 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM VTICM512.1 IMPLANTABLE COLLAMER LENS OF A -10.5 DIOPTER, WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2024, THE LENS WAS REMOVED DUE TO ELEVATED IOP WITHOUT PUPIL BLOCK AND ANGLE CLOSURE. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459865 ↗
• MalfunctionApr 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.1MM VICM5 12.1, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED AND REPLACED INTRAOPERATIVELY WITH A LONGER LENGTH LENS ON (B)(6) 2024 FROM PATIENT'S RIGHT EYE (OD) DUE TO LOW VAULT.THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS DEVICE: REINSTEIN FORMULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021321 ↗
• MalfunctionMar 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.1MM VICMO12.1, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED, REMOVED, AND REPLACED WITH A SAME LENGTH LENS INTRAOPERATIVELY ON (B)(6) 2023 FROM PATIENT'S RIGHT EYE (OD) DUE TO LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE EYE. PATIENT CONTACT BUT NO PATIENT INJURY. . THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886349 ↗
• InjuryJan 9, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICM5 12.1, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS FROM THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023. A LONGER LENGTH LENS WAS IMPLANTED ON (B)(6) 2023 DUE TO LOW VAULT. THIS DID NOT RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN. REPORTEDLY, LENS SIZE INCREASED BUT LOW VAULT NOT RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473814 ↗
• MalfunctionNov 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS -10.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023 AS A REPLACEMENT LENS TO ADDRESS EXCESSIVE VAULT. IT WAS REPORTED THAT THE PROBLEM RESOLVED, HOWEVER "STABLE WITH LOW VAULT" WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243698 ↗
• InjuryOct 3, 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 12.1MM VICM5_12.1, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REPLACED WITH A LONGER LENGTH SPHERICAL LENS ON (B)(6) 2023 DUE TO LOW VAULT. THIS DID NOT RESOLVE THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR, LENS TOO SHORT. REPORTEDLY, LOW VAULT CONTINUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862027 ↗
• MalfunctionJul 13, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON ATTEMPTED TO IMPLANT A 12.1MM VICM5_12.1; -10.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS NO PATIENT CONTACT. ON THIS SAME DATE A REPLACEMENT LENS WAS LATER IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321923 ↗
• InjuryMay 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.5 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. TTHE LENS WAS REMOVED ON (B)(6)2023 DUE TO LOW VAULT. THAT SAME DAY, THE LENS WAS REPLACED WITH A LONGER LENGTH LENS ALTHOUGH IT IS UNCLEAR WHETHER THIS WAS WITHIN THE SAME PROCEDURE. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027935 ↗
• InjuryMay 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.5 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO LOW VAULT. THAT SAME DAY, THE LENS WAS REPLACED WITH A LONGER LENGTH LENS ALTHOUGH IT IS UNCLEAR WHETHER THIS WAS WITHIN THE SAME PROCEDURE. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17027930 ↗
• InjuryDec 16, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.1MM VICM5_12.1 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE PATIENT EXPERIENCED LOW VAULT, 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 15993588 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.