EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-11.0/1.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542116725), received between Feb 21, 2023 and Jan 29, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2, -11.0/1.5/091 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. A REACTIVE BUT LARGE PUPIL WAS OBSERVED. EYE DROPS WERE PRESCRIBED. PROBLEM RESOLVED. THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN. REPORTEDLY, BRIMONIDINE DROPS HELP TREMENDOUSLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18596265 ↗
• MalfunctionJan 12, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS OF -11.00/1.5/087 (SPHERE/CYLINDER/AXIS) TORE DURING INSERTION PROCESS, USED BACKUP LENS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509225 ↗
• MalfunctionDec 20, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICMO 13.2 IMPLANTABLE COLLAMER LENS OF -14.00 DIOPTER LENS TORE DURING INJECTION/DELIVERY INTO THE RIGHT EYE (OD). ON (B)(6) 2023 THE LENS WAS IMPLANTED, REMOVED INTRA-OPERATIVELY. A REPLACEMENT LENS WAS LATER IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369534 ↗
• MalfunctionSep 18, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -11.00/1.5/106 (SPHERE/CYLINDER/AXIS) LENS TORE WHILE LOADING; NO PATIENT CONTACT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769891 ↗
• InjuryMar 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -11.0/1.5/092 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED AND LATER REPLACED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644571 ↗
• MalfunctionFeb 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.7MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -11.00/1.5/090 (SPHERE/CYLINDER/AXIS) LENS TORE DURING INJECTION AND ALSO GOT STUCK IN CARTRIDGE ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS IMPLANTED REMOVED AND REPLACED INTRAOPERATIVELY FOR SPHERICAL LENS OF THE SAME SIZE AND THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS DEVICE. "THE LENS WOULD NOT STAY FORWARD IN THE SHOOTER AND IT CONTINUED TO SLIP BACKWARDS AND GOT CAUGHT DURING INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428877 ↗
• InjuryFeb 21, 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; -11.0/1.5/047 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6)2023. THE PATIENT EXPERIENCED LOW VAULTING. ON (B)(6) 2023 THE LENS WAS EXPLANTED. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS "OTHER" AND NOTED "LONGER LENGTH NEEDED"; THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. IT WAS ADDITIONALLY NOTED "EXPLANTED ICL UNTIL LONGER LENGTH RECEIVED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413690 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.