EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-12.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542119450), received between Aug 5, 2022 and Oct 1, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Sep 29, 2023Class IIOpen, Classified

   Their is a potential that intraocular implant devices may not meet specifications.

   Z-0466-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

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.

• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE DOCTOR OBSERVED UNUSUAL GLISTENING ON THE LENS OPTIC. LENS WAS REMOVED. CAUSE OF EVENT WAS NOT REPORTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346387 ↗
• InjurySep 23, 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 EXCESSIVE VAULT. DUE TO EXCESSIVE VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS OTHER. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20283301 ↗
• MalfunctionApr 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -12.0 WAS DAMAGED WITH A TEAR IN THE CORNER. PATIENT CONTACT OR CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042118 ↗
• InjuryOct 3, 2023Off-Label Use; Patient-Device Incompatibility; No Apparent Adverse Event; Off-Label Use; Patient-Device Incompatibility; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -12.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS). REPORTEDLY, HYPEROPIC SURPRISE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865117 ↗
• MalfunctionJul 22, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -12.00 DIOPTER TORE DURING LOADING. THE LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375627 ↗
• InjuryDec 30, 2022Optical Problem; Optical Problem

  THE REPORTER (CONSUMER) INDICATED THAT AN EVO ICL WAS IMPLANTED INTO THE PATIENTS EYE AND "HALOS ARE SO BAD AT NIGHT."NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Halo

  MAUDE report 16080994 ↗
• InjuryAug 5, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.00 DIOPTER, INTO THE PATIENTS LEFT EYE (OS). THE LENS WAS REMOVED DUE TO OVERVAULT. THE LENS WAS REPLACED WITH A SHORTER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178233 ↗

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-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.
• 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.