EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-9.5/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311308095), received between Jul 24, 2023 and Nov 10, 2025 — classified as 7 injuries, 3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 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 A LOW VAULT WITH ROTATION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THE REPLACEMENT LENS RESOLVED THE PROBLEM. CAUSE REPORTED AS USER ERROR. 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 23518877 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LENS ROTATION NOT ASSOCIATED WITH LOW VAULT, GLARES/HALOES AND BLURRED VISION. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. ON THE SAME DAY SEPARATE SURGERY A REPLACEMENT LENS OF A LONGER LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER/UNKNOWN. CAUSE DETAILS PROVIDED: "DESPITE HAVING A GOOD VAULT, THE LENS ROTATED 90 DEGREES. I DID DOWNSIZE FROM THE RECOMMENDED LENS DUE TO HER WTW, BUT THE VAULT WAS WITHIN NORMAL LIMITS." IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 21280121 ↗
• InjuryDec 4, 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 LENS ROTATION NOT ASSOCIATED WITH LOW VAULT. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR THE SAME MODEL/LONGER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE. THEREFORE, THERE IS NOT ENOUGH SAFETY AND EFFECTIVENESS DATA TO SUPPORT IMPLANTATION IN THIS PATIENT CATEGORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845251 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. AT A LATER DATE, THE LENS WAS REMOVED AND EXCHANGED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605688 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM5 -9.50/+1.50/090 IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN VISCOELASTIC, THE MSI INJECTOR SYSTEM, AND INTRACAMERAL ANTIBIOTIC/SOLUTIONS (UNSPECIFIED). TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED WITH PRESENTATION OF ANTERIOR CHAMBER "ABSCESS". PUPIL BLOCK WITH ELEVATED IOP WAS ALSO OBSERVED. SECONDARY ANTERIOR CHAMBER IRRIGATION AND EVACUATION OF VISCO/FLUIDS WAS PERFORMED. UPON ADDITIONAL SURGICAL AND MEDICAL INTERVENTION, THE REPORTED ISSUES IMPROVED. LAST REPORT ON DAY 13 STATES PATIENT WAS RECOVERING WITH UNAIDED "NAKED EYE" (UCVA) VISION IMPROVED TO 1.0 (20/20). THE LENS REMAINS IMPLANTED. IN THE REPORTER'S OPINION THE CAUSE OF THE EVENT IS THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Pupillary Block; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19641547 ↗
• InjuryMay 1, 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, -9.5/1.5/082 (SPHERE/CYLINDER/AXIS) DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS ON (B)(6) 2024 DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE CAUSE OF EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222499 ↗
• MalfunctionApr 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_ 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -9.5/1.5/014 (SPHERE/CYLINDER/AXIS) TORE/BROKE DURING INJECTION/ DELIVERY INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. ON (B)(6) 2024 A REPLACEMENT LENS OF THE SAME LENGTH/MODEL WAS IMPLANTED. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN - 'LENS GOT STUCK IN THE PLUNGER'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175876 ↗
• MalfunctionMar 21, 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 IMPLANTABLE COLLAMER LENS OF -9.5/1.5/109 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024 AS A REPLACEMENT LENS TO ADDRESS LOW VAULT. IT WAS REPORTED THAT THE VAULT ISSUE RESOLVED (GOOD VAULT). FOR STATUS OF THE EYE CORNEAL EDEMA WITH A.C. ACTIVITY WAS REPORTED. SEE MFR # 2023826-2024-01331 FOR CLAIM AGAINST THE INITIAL LENS.

  Patient problems: Corneal Edema

  MAUDE report 18955007 ↗
• InjuryDec 19, 2023Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -9.50/1.5/113 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. LOW VAULT WAS OBSERVED, LENS REMAINS IMPLANTED. CAUSE OF EVENT WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18353416 ↗
• MalfunctionJul 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.50/+1.5/069 (SPHERE/CYLINDER/AXIS). DURING THE SAME SURGERY DUE TO THE LENS BECAME STUCK IN THE CARTRIDGE AND WAS TORN/BROKEN DURING INJECTION/DELIVERY INTO THE PATIENTS LEFT EYE (OS). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AT A LATER DATE AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386298 ↗

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