EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-13.0/2.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542117029), received between Mar 29, 2023 and May 12, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 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 IMPLANTABLE COLLAMER LENS OF DIOPTER -13.00/2.5/140 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD). THE PATIENT EXPERIENCED AN EXCESSIVE VAULT AND ANGLE CLOSURE. REPORTEDLY "DURING AN INTRODUCTORY CONVERSATION, THE SURGEON INFORMED ME THAT HE HAS A PATIENT WHO WILL NEED AN EXPLANT DUE TO VERY HIGH VAULT AND ANGLE CLOSURE". THE LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19295885 ↗
• InjuryJan 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -13/2.5/112 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON REPORTS THE PATIENT HAS EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. ON (B)(6) 2024 THE SURGEON INDICATES HE WILL EXPLANT AND REPLACE THE LENS. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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 18428711 ↗
• MalfunctionJun 20, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, VTICM5_13.2, -13.0/2.5/110 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023.THE LENS TORE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY ON (B)(6) 2020. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN, DEVICE FAILED TO PERFORM AS INTENDED. REPORTEDLY, TEAR SPLITTING THE CENTRAL OPTIC WHICH PRGINATED FROM THE LEADING EDGE. PATIENT DOING EXCELLENT WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163485 ↗
• MalfunctionMar 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2 -13.00/2.5/095 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6), 2023. LENS ROTATION AFTER IMPLANT WAS OBSERVED, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639377 ↗

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-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.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-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.