EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-9.5/2.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840311311736), received between Jan 8, 2024 and Oct 24, 2025 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 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 SHALLOWING OF THE ACD WITH A SIGNIFICANT REDUCTION IN IRIDOCORNEAL ANGLES AND PUPIL IMPAIRMENT. REPORTEDLY, "ANTERIOR CHAMBER ANGLES ODS ARE VERY SHALLOW 1 YEAR POST OP WITH NORMAL PRESSURE" AND "PUPIL ASYMMETRIC - ELONGATED TEMPORALLY". THE LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 23383666 ↗
• InjuryJul 18, 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 LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. THE LENS EXPLANTED AND REPLACED AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS DEVICE, "AFTER REPOSITION, ICL ROTATES MORE THAN 90 DEGREES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542651 ↗
• InjuryMay 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 LOW VAULT WITH ROTATION. DUE TO LOW VAULT WITH ROTATION, THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 22023055 ↗
• InjuryJun 18, 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 VTICM5_13.2, -9.5/2.0/090 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2024. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558882 ↗
• MalfunctionJan 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON 30-NOV-2023 A 13.2MM, VTICM5_13.2, -9.5/2.0/083 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE LEFT EYE (OS). THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY. THERE WAS NO PATIENT INJURY. ON (B)(6) 2023 A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18472164 ↗

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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-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.