EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-8.5/2.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840311311712), received between Jan 6, 2023 and Aug 25, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse 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 and Significant shallowing of the AC. In a separate surgery the lens was exchanged with a shorter length and the problem was resolved. The cause of the event was reported as unknown. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50438825 ↗
• InjuryOct 16, 2025Adverse 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 GLARES/HALOES AND BLURRED VISION. THE LENS WAS EXPLANTED AND PROBLEM RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. 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: Blurred Vision

  MAUDE report 23318356 ↗
• InjuryJan 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION AND REFRACTIVE ERROR. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097492 ↗
• InjuryNov 25, 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 LOW VAULT AND RECURRENT IRITIS. LENS WAS EXPLANTED. CAUSE OF EVENT WAS NOT REPORTED.

  Patient problems: Iritis

  MAUDE report 20775898 ↗
• InjuryMay 14, 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; -8.50/2.0/092 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. THE LENS WAS EXPLANTED. THE LENS WAS LATER REPLACED WITH A SHORTER LENGTH LENS. NO POST EXCHANGE DATA WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316271 ↗
• InjuryMar 25, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -9.0/3.0/091 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). THE SURGEON REPORTS THE PATIENT HAS EXCESSIVE VAULTING WITH A PLANNED LENS EXCHANGE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969829 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT ON 20-SEP-2023 A 13.2MM, VTICM5_13.2, -8.50/2.0/089 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS GOT STUCK IN THE PLUNGER AND WAS NOTICED TO BE TORN/BROKEN WHEN DELIVERED IN THE EYE WHILE MANIPULATING THE HAPTICS. ON (B)(6) 2023 THE LENS WAS EXCHANGED AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18089677 ↗
• InjuryJan 6, 2023Misfocusing; Improper or Incorrect Procedure or Method; Misfocusing; Improper or Incorrect Procedure or Method

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -8.5/2.0/130 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. REFRACTIVE CHANGE OVERTIME WAS OBSERVED. CAUSE OF THE EVENT WAS USER ERROR. REPORTEDLY, "SURGEON USED WRONG DATAS FOR CALCULATION IN OCOS, DATA FOR OD USED FOR OS.

  Patient problems: Blurred Vision

  MAUDE report 16117774 ↗

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