EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-5.5/1.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840311307739), received between May 26, 2023 and Jun 15, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 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. LENS REPOSITIONED. LENS EXCHANGED WITH LONGER LENGTH LENS. PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25504530 ↗
• InjuryDec 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 TRANSIENT LOSS OF BCVA. THE LENS WAS EXCHANGED FOR A DIFFERENT DIOPTER LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR.

  Patient problems: Blurred Vision

  MAUDE report 23845121 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS WAS REMOVED. THIS WAS REPORTEDLY DUE TO "PERSISTENT DECENTRATION/UGH DUE TO INSUFFICIENT ZONULE/SULCUS SUPPORT IN A PSEUDOPHAKIC PATIENT." 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: Iritis; Uveitis

  MAUDE report 22333702 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDICAL PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. IN A SEPARATE VISIT THE LENS WAS ROTATED/ REPOSITIONED. MEDICATION WAS PRESCRIBED. AT A LATER DATE THE LENS WAS EXCHANGED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 21260159 ↗
• MalfunctionNov 21, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750795 ↗
• InjuryNov 13, 2024Adverse 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 AN EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED WITH THE SAME MODEL, SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675453 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. THE LENS WAS REMOVED AND EXCHANGED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615913 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 -5.50/1.00/180 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6)2024. THE PATIENT UNDERWENT SAME DAY BILATERAL ICL IMPLANTATION. OPEGAN OVD WAS USED INTRAOPERATIVELY. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS OBSERVED BILATERALLY SAME DAY UPON LENS IMPLANTATION. INFLAMMATION WAS CONFIRMED BY OCT IMAGING. IN THE REPORTER OPINION THE CAUSE IS UNKNOWN. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19068725 ↗
• MalfunctionOct 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 -5.50/+1.00/004 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. WITHIN THE INITIAL SURGERY THE LENS WAS REMOVED AND REPLACED INTRA-OPERATIVELY FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17947870 ↗
• InjuryAug 2, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -5.50/1.0/113 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE WHICH WAS NOTED ON (B)(6) 2023. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 17446725 ↗
• MalfunctionMay 26, 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 -5.5/+1.0/085 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. WITHIN THE INITIAL SURGERY THE LENS WAS REMOVED AND REPLACED INTRA-OPERATIVELY FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015327 ↗

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