EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-3.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840311300808), received between Dec 12, 2022 and Sep 25, 2026 — classified as 13 injuries.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision

  MAUDE report 50905613 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. IN A SEPARATE SURGERY THE LENS WAS EXPLANTED, ON THE SAME DAY SEPARATE SURGERY REPLACED WITH SHORTER LENGTH/ DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 24300013 ↗
• InjuryOct 16, 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 REFRACTIVE SURPRISE. MEDICATION WAS ADMINISTERED AND THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 23318355 ↗
• InjuryApr 30, 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 REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL LENS AND PROBLEM RESOLVED. CAUSE WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 21938614 ↗
• InjuryApr 29, 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 GLARES/HALOS. REFRACTIVE TREATMENT WAS PERFORMED. THE LENS WAS EXPLANTED AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 21930031 ↗
• InjuryFeb 6, 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 PERMANENT LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). DUE TO PERMANENT LOSS OF BEST CORRECTED VISUAL ACUITY, THE LENS WAS EXPLANTED. THE PROBLEM WAS RESOLVED. CAUSE OF THE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326476 ↗
• InjurySep 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 EXCESSIVE VAULT AND SIGNFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THE LENS WAS REMOVED AND REPLACED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201589 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VICM5 -3.50D IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL IMPLANTATION OF ICLS. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN VISCOELASTIC AND THE MSI INJECTOR SYSTEM. ON DAY 1 TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. NO DIAGNOSTICS TESTS WERE PERFORMED. THE LAST REPORT ON DAY 1 STATES THERE WERE NO ABNORMALITIES IN VISION OR SYMPTOMS BUT MINOR FIBRIN AND PIGMENTATION WERE IDENTIFIED. STEROID OPHTHALMIC DROPS WERE PRESCRIBED AND THE SYMPTOMS SUBSIDED THE NEXT DAY. IN THE REPORTER'S OPINION THE CAUSE IS REPORTED AS UNKNOWN. THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19455536 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -3.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). 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 1.0 (~20/20) TO 1.2 (~20/15). THE LENS REMAINS IMPLANTED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19102334 ↗
• InjuryDec 29, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -3.50 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 LENS REPOSITIONING WAS PERFORMED DUE TO EXCESSIE VAULT BUT THE PROBLEM DID NOT RESOLVE. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THIS EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418705 ↗
• InjuryDec 13, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -3.5 DIOPTER INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED DUE TO REFRACTIVE CHANGE OVERTIME. ON (B)(6) 2023 A REPLACEMENT LENS OF DIFFERENT POWER WAS IMPLANTED AND THE PROBLEM RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18323057 ↗
• InjuryJul 5, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF -3.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262134 ↗
• InjuryDec 12, 2022Misfocusing; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -03.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022; AS A REPLACEMENT LENS. IT WAS INDICATED THAT THE PATIENT EXPERIENCED LOW VAULTING WITH RESIDUAL ASTIGMATISM. LENS REMAINS IMPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 15964379 ↗

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