EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-6.5/1.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840311311118), received between Apr 17, 2023 and Feb 10, 2025 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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.

• InjuryFeb 10, 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 UVEITIS/IRITIS. DIAGNOSTIC CULTURES WERE NOT PERFORMED. THE PATIENT WAS TREATED WITH "STEROID MEDICATION AND/OR EYE DROPS" IN A SEPARATE VISIT THE LENS WAS EXPLANTED, AND THE PROBLEM WAS RESOLVED.

  Patient problems: Iritis; Uveitis

  MAUDE report 21349739 ↗
• InjuryDec 11, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULTING. THE LENS REMAINED IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907101 ↗
• MalfunctionNov 27, 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 REFRACTIVE SURPRISE. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 20794003 ↗
• 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 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -06.50/+1.0/108 (SPHERE/CYLINDER/AXIS) INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS EXPLANTED ON (B)(6) 2024, DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839326 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 IMPLANTABLE COLLAMER LENS OF -6.50/1.00/180 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023 AS AN EXCHANGE LENS. THE SURGEON SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). DIAGNOSTIC CULTURES WERE NOT PERFORMED. OPEGAN OCULAR VISCOELASTIC DEVICE WAS USED FOR THE CASE. NO LOSS OF VISUAL ACUITY WAS REPORTED. THE LENS REMAINS IMPLANTED. IN THE REPORTER'S OPINION THE CAUSE OF THIS EVENT WAS DUE TO THE DEVICE. SEE MFR# 2024-00615 FOR INITIAL LENS.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18725352 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 IMPLANTABLE COLLAMER LENS OF -6.50/+1.00/180 (SPHERE/CYLINDER/AXIS) POWER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE SURGEON SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). DIAGNOSTIC CULTURES WERE NOT PERFORMED BUT ANTERIOR CHAMBER LAVAGE WAS COMPLETED, AND TOPICAL STEROIDS WERE PRESCRIBED. OPEGAN OCULAR VISCOELASTIC DEVICE WAS USED FOR INITIAL LENS IMPLANTATION. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR AN ICL OF SAME MODEL, SIZE AND POWER. NO LOSS OF VISUAL ACUITY WAS REPORTED. IN THE REPORTER'S OPINION THE CAUSE OF THIS EVENT WAS DUE TO THE DEVICE. SEE MFR # 2024-00616 FOR EXCHANGE LENS.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18725342 ↗
• InjuryOct 10, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -6.5/+1.0/166 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT AND LENS ROTATION. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT REPORTED AS UNKNOWN AND IT WAS REPORTED THAT THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908786 ↗
• MalfunctionOct 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2, -6.5/1.0/171 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS FOR PATIENT'S LEFT EYE (OS) DAMAGED DURING LENS SETTING ON (B)(6) 2023. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862031 ↗
• InjuryAug 10, 2023Inadequacy 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; -6.50/+1.0/75 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING, ELEVATED INTRAOCULAR PRESSURE WITHOUT PUPIL BLOCK, SIGNIFICANT REDUCTION OF IDIRO-CORNEAL ANGLES, ADDITIONALLY MEDICAL INTERVENTION OF COMBIGAN AND COSOPT 3 TIMES A DAY. LENS REMAINS IMPLANTED. THE PROBLEM IS NOT RESOLVED. THE SURGEON NOTED THERE IS A PLANNED LENS EXCHANGE.

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

  MAUDE report 17502541 ↗
• MalfunctionJun 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -6.5/1/101 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. THE LENS HAD TORE BEFORE/DURING LOADING, AFTER OPENING THE VIAL, THE LENS WAS STUCK IN CARTRIDGE OR INJECTION SYSTEM AND TORE DURING INJECTION/DELIVERY INTO THE EYE. INTRAOPERATIVELY THE LENS WAS REMOVED WITH NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210600 ↗
• InjuryApr 17, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM513.2, -6.5/1.0/090 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2023. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750655 ↗

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