EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-14.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311301010), received between Dec 4, 2023 and Dec 2, 2025 — classified as 3 injuries, 4 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 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 EXCESSIVE VAULT, GLARES/HALOES, DOUBLE VISION & BLURRED VISION. THE LENS WAS EXPLANTED & REPLACED WITH A SHORTER LENGTH LENS & IT WAS STATED THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23697976 ↗
• InjuryMay 22, 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. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. ON SAME DAY DIFFERENT SURGERY A REPLACEMENT LENS OF SAME MODEL AND SIZE BUT DIFFERENT DIOPTER WAS IMPLANTED. CAUSE REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 22075690 ↗
• 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 ELEVATED IOP AND PIGMENT DISPERSION. REPORTEDLY, "A PATIENT WITH PIGMENT DISPERSION 30 DAYS AFTER SURGERY AND WITH PRESSURE ELEVATION TO 20." THE PATIENT HAD BEEN PRESCRIBED TOPICAL ANTIBIOTICS AND NSAID EYEDROPS BEFORE BEING COMMENCED ON TOPICAL STEROIDS AND LUBRICANTS. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939709 ↗
• MalfunctionMar 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -14.0 DIOPTER WAS INTRAOPERATIVELY IMPLANTED AND REMOVED DUE TO THE LENS BEING UPSIDE DOWN WITHIN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PROBLEM WAS NOT RESOLVED. CAUSE OF THE EVENT WAS USER ERROR. IT WAS REPORTED THAT THE LENS WAS IMPLANTED UPSIDE DOWN AND TORN DURING EXPLANTATON. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961248 ↗
• MalfunctionDec 28, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED LOW VAULTING WITHOUT ROTATION. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414875 ↗
• MalfunctionDec 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -14.0 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED LOW VAULTING WITHOUT ROTATION. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401524 ↗
• MalfunctionDec 4, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2. -14.0 DIOPTER IMPLANTABLE COLLAMER LENS LENS TORE/BROKE DURING LOADING. DAMAGE WAS NOTED WHILE REMOVING FROM VIAL. BACK UP LENS IMPLANTED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258249 ↗

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