EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-14.0/3.0)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840311309023), received between Jul 25, 2023 and Aug 11, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  The reporter indicated that following an implantable collamer lens (ICL) implantation procedure, the patient experienced capsular tear. The lens was explanted. Proceeded with refractive lens exchange. The problem was resolved. Cause of the event was reported as anterior capsular tear.

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

  MAUDE report 50212312 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND LENS ROTATION. THE LENS WAS REPOSITIONED. THIS DID NOT RESOLVE THE PROBLEM. THE LENS WAS EXPLANTED. ON THE SAME DAY THE LENS WAS REPLACED VERTICALLY WITH A SAME MODEL, POWER BUT LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

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

  MAUDE report 25568485 ↗
• InjurySep 4, 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 LENS ROTATION. LENS WAS INTRAOPERATIVELY REMOVED AND REPLACED VERTICALLY WITH A LONGER LENGTH, DIFFERENT DIOPTER LENS. PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138210 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS -14.00/+3.0/077 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS REPORTED AS HAVING EXCESSIVE VAULTING, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, ELEVATED IOP. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A SMALLER LENGTH LENS. PROBLEM RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 18842173 ↗
• MalfunctionFeb 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2024 A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -14.00/3.0//100 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED UPSIDE DOWN INTO THE PATIENTS RIGHT EYE (OD). THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY WITH NO PATIENT INJURY. LENS BROKE DURING REMOVAL. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18736027 ↗
• MalfunctionFeb 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6)2024 A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -14.00/3.0//100 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED UPSIDE DOWN INTO THE PATIENTS RIGHT EYE (OD). THE LENS WAS REMOVED INTRAOPERATIVELY WITH NO PATIENT INJURY. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18736009 ↗
• InjuryJan 20, 2024Inadequacy 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 -14.0/3.0/082 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548587 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, VTICM5_12.6, -14.0/3.0/043 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ELEVATED IOP(32MMHG) WITH OUR PUPIL BLOCK AND ANGLE CLOSURE(ASSESSED ON 3RD WEEK POST-OP), PIGMENT DISPERSION WERE OBSERVED. LENS REMAINS IMPLANTED. PATIENT GIVEN STEROIDS AND IOP MEDS. THIS HAS NOT RESOLVED THE PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 18525773 ↗
• InjuryJul 25, 2023Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM, VTICM5_12.6, -14.0/3.0/090 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2023 THE LENS WAS REPLACED WITH A SAME SIZE , SIMILARE (SPHERE/CYLINDER/AXIS) LENS DUE TO REFRACTIVE SURPRISE AND TOXIC ANTERIOR SEGMENT SYNDROME(TASS, EYE DROP TREATMENT PERFORMED). THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS OTHER, TASS CAUSED BY INJECTOR, ASTIGMATISM CORRECTION.

  Patient problems: Blurred Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 17391254 ↗

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-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.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.