EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-11.5/1.0) (REF VTICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311304493), received between Dec 5, 2023 and Jun 26, 2025 — classified as 3 injuries, 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 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 LOW VAULT WITH ROTATION. DUE TO LOW VAULT WITH ROTATION, THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE IS UNKNOWN. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE 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. 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 22341368 ↗
• MalfunctionApr 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2024, A 12.1MM VTICM512.1 IMPLANTABLE COLLAMER LENS OF A -11.5/1.0/091 (SPHERE/CYLINDER/AXIS) BECAME STUCK IN THE CARTRIDGE OR INJECTION SYSTEM. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. REPORTEDLY, "WHEN THE LENS LOADED, THE PLUNGER IS PRESSED BEFORE BRINGING THE LENS TO THE TIP." CAUSE OF THE EVENT WAS USER ERROR. THE LENS WAS PREPARED AGAIN AND SURGERY WAS PERFORMED ON ANOTHER DAY. ON (B)(6) 2024, A LONGER LENGTH REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122212 ↗
• MalfunctionApr 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2024, A 12.1MM (B)(6) IMPLANTABLE COLLAMER LENS OF (B)(6) (SPHERE/CYLINDER/AXIS) BECAME STUCK IN THE CARTRIDGE OR INJECTION SYSTEM. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. REPORTEDLY, "WHEN THE LENS LOADED, THE PLUNGER IS PRESSED BEFORE BRINGING THE LENS TO THE TIP." CAUSE OF THE EVENT WAS USER ERROR. THE LENS WAS PREPARED AGAIN AND SURGERY WAS PERFORMED ON ANOTHER DAY. ON (B)(6) 2024, A LONGER LENGTH REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122211 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM, VTICM5_12.1, -11.5/1.0/081 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. PIGMENT DISPERSION, UNREACTIVE (FIXED) PUPIL, ANTERIOR CHAMBER FLARE, AND LENS ROTATION NOT ASSOCIATED TO A LOW VAULT WAS OBSERVED. LENS REPOSITIONED ON (B)(6) 2024. THIS DID NOT RESOLVE THE PROBLEM. EYE DROPS PRESCRIBED. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS, THIS DID NOT RESOLVED THE PROBLEM.

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

  MAUDE report 19021317 ↗
• MalfunctionJan 22, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.1MM, VTICM5_12.1 -11.5/1.0/081 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS TORE/BROKE BEFORE LOADING. IT WAS REPORTED THAT THE SURGEON BELIEVES THAT THE LENS WAS DAMAGED DURING REMOVAL FROM LENS VIAL. THERE WAS NO PATIENT CONTACT. ON (B)(6) 2023 A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18560094 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM VTICM5_12.1 IMPLANTABLE COLLAMER LENS OF -11.5/1.0/179 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6)2023 THE LENS WAS EXPLANTED DUE TO ELEVATED IOP (INTRAOCULAR PRESSURE) ANS PAIN. THE EXPLANT RESOLVED THE PROBLEM.

  Patient problems: Eye Pain; Intraocular Pressure Increased

  MAUDE report 18271533 ↗

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