EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.0/2.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311308446), received between Jun 14, 2023 and Feb 9, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• InjuryFeb 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 LENS ROTATION AND BLURRY VISION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THE REPLACEMENT RESOLVED THE PROBLEM.

  Patient problems: Blurred Vision

  MAUDE report 24295428 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING TO AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION THE PATIENT EXPERIENCED LENS ROTATION, BLURRED VISION, AND THE LENS EXPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 23583414 ↗
• InjuryJan 27, 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 LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT, THE LENS WAS REPOSITIONED. THIS DID NOT RESOLVE THE ISSUE. THE LENS WAS THEN EXCHANGED FOR A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21244365 ↗
• InjuryAug 28, 2024Adverse 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 EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. IT HAS BEEN NOTED THAT THE SURGEON ELECTED A DIFFERENT LENGTH LENS 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. CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091831 ↗
• InjuryOct 17, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -13.0/+2.0/091 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953989 ↗
• InjurySep 25, 2023Misfocusing; Device Dislodged or Dislocated; Misfocusing; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -13.0/2.0/103 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE DID NOT PERFORM AS INTENDED. REPORTEDLY,"OS ICL HAS ROTATED AT 8 WEEKS POST-OP. CAUSE UNKNOWN." STATUS OF EYE IS STATED, "DECREASED VISION, BURNING SENSATION," AND "PATIENT HAD ICL INSERTED ON (B)(6) 2023. SURGERY WAS ROUTINE, AND ICL WAS INSERTED INTO THE SULCUS AT THE TARGET AXIS OF 175 DEGREES (5 DEGREE ROTATION). VISION WAS 6/6 (20/20) POST OP, INCLUDING UPON EXAMINATION ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT PRESENTED TO THE CLINIC WITH BLURRED VISION WHICH HAD STARTED THAT MORNING AND WAS NOT PRESENT BEFORE GOING TO BE THE NIGHT BEFORE. NO PAIN WAS NOTED BUT PATIENT MENTIONED THE EYE FELT A BURNING SENSATION 4 DAYS EARLIER, PRIOR TO VISION CHANGE. NO TRAUMA WAS NOTED BY THE PATIENT. UPON EXAMINATION THE ICL HAD ROTATED TO AN AXIS OF 70 DEGREES SINCE THE LAST POST-OP VISIT."

  Patient problems: Blurred Vision

  MAUDE report 17814901 ↗
• InjuryJun 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -13.0/2.0/094 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE AND NOTED IT HAD ROTATED DAYS AFTER. ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A SAME LENGTH LENS AND THIS RESOLVED THE PROBLEM. THERE WAS NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131362 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.