EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-12.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840311300983), received between Jul 25, 2023 and Jun 9, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 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 OVER/UNDER CORRECTION. LENS EXCHANGED WITH DIFFERENT DIOPTER LENS. PROBLEM 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. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25439025 ↗
• InjuryMar 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 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. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR.

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

  MAUDE report 24640871 ↗
• InjuryDec 4, 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 OVER/UNDER CORRECTION. OTHER SURGICAL INTERVENTION WAS PERFORMED: LRIS. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 23722999 ↗
• MalfunctionNov 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT, PIGMENT DISPERSION AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. DUE TO EXCESSIVE VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20644810 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 -12.50D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. PRODUCT NONCONFORMITY OBSERVED; LENS POWER DIFFERENCE SUSPECTED. LENS WAS EXCHANGED ON (B)(6) 2024 BUT PROBLEM WAS NOT RESOLVED. CAUSE OF EVENT WAS REPORTED AS DEVICE; DEVICE DID NOT FAIL TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372622 ↗
• InjuryJan 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.7MM VICM5_13.7 IMPLANTABLE COLLAMER LENS OF -12.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THE EXCHANGE RESOLVED THE PROBLEM, THE REPORTER STATED " VAULT REDUCED TO NORMAL AND PATIENT IS DOING GOOD". CAUSE OF EVENT WAS UNKNOWN.

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

  MAUDE report 18472104 ↗
• MalfunctionDec 29, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -12.5 DIOPTER TORE/BROKE DURING LOADING AFTER OPENING THE VIAL. A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON 19-JUL-2023 AND THE PROBLEM WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18421055 ↗
• InjuryDec 29, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT ON A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -12.5 WAS IMPLANTED AS A REPLACEMENT INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS EXCHANGED FOR A TORIC LENS DUE TO REFRACTIVE SURPRISE. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 18421048 ↗
• MalfunctionJul 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -12.50 DIOPTER TORE DURING INJECTION, INTRAOPERATIVELY THE LENS WAS REMOVED WITH PATIENT INJURY OF POSTOP CORNEAL EDEMA. SURGEON ALSO NOTED PATIENT HAD BLURRED VISION. A REPLACEMENT LENS OF THE SAME LENGTH WAS IMPLANTED ON THIS SAME DATE. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND THERE IS DEVICE CAUSALITY.

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 17393103 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.