EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.0/2.0) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542115124), received between Dec 2, 2022 and Sep 16, 2024 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 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 TOO SMALL. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER STAAR LENS. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. CAUSE OF THE EVENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20227510 ↗
• InjuryNov 14, 2023Adverse 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, -11.00/+2.0/090 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT WAS FOUND TO HAVE ENDOPHTHALMITIS AND PERMANENT LOSS OF BCVA. INTRAOCULAR PRESSURE (IOP) CHECK AND ANTERIOR SEGMENT IMAGING WERE PERFORMED ON (B)(6) 2023. PATIENT WAS PRESCRIBED MEDICATIONS FOR INCREASED IOP. PATIENT HAD HYPOPYON, FIBRIM NET, CELLS IN AC, WITH REDNESS, SEVERE LIGHT SENSITIVITY AND PAIN, INITIALLY DIAGNOSED AS TASS DUE TO FAST COURSE OF SIGNS AND CLEAR B-SCAN BY DOCTOR AND RETINAL SPECIALIST. PATIENT HAD VITREOUS BIOPSY WITH INTRAVITREAL INJECTION OF VANCOMYCIN AND CEFTAZIDIME TO RULE OUT AND TREAT ENDOPHTHALMITIS AS WELL AS SUBTENON KENALOG DUE TO INITIAL FAST COURSE OF SIGNS OF TASS. THE NEXT DAY, DUE TO CELLS ON VITREOUS B-SCAN, THE PATIENT HAD BILATERAL PPV (PARS PLANA VITRECTOMY) WITH INTRAVITREAL INJECTION OF CEFTAZIDIME, VANCOMYCIN AND VITREOUS CULTURE. VITREOUS CULTURE GREW PSEUDOMONA AERUGINOSA AND CURRENTLY THE PATIENT IS HOSPITALIZED. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

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

  MAUDE report 18136571 ↗
• InjuryMay 1, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -11.00/2.0/035 (SPHERE/CYLINDER/AXIS) WAS REMOVED (EXPLANTED) DUE TO THE LENS TURNING UPSIDE DOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850728 ↗
• InjuryDec 2, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -11.00/+2.0/079 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS REMOVED ON (B)(6) 2022 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15909566 ↗

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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.