EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-13.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840311301003), received between Jun 14, 2023 and Jan 21, 2026 — classified as 3 injuries, 4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SAME MODEL/ LENGTH, DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 24135008 ↗
• InjuryJul 24, 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 ELEVATED IOP. THE LENS WAS REPOSITIONED ON (B)(6) 2024. THIS DID NOT RESOLVE THE PROBLEM. THE LEN WAS REMOVED. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 19822725 ↗
• MalfunctionFeb 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON ATTEMPTED TO INSERT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -13.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS) BUT THE LENS BECAME STUCK IN THE CARTRIDGE OR INJECTION SYSTEM AND TORE/BROKE DURING INJECTION. THERE WAS PATIENT CONTACT BUT NO INJURY. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691885 ↗
• MalfunctionDec 15, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -13.50 DIOPTER, TORE/BROKE BEFORE/DURING LOADING AND WAS STUCK IN THE CARTRIDGE OR INJECTION SYSTEM. THERE WAS NO PATIENT CONTACT OR INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337630 ↗
• MalfunctionNov 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -13.5 DIOPTER LENS TORE DURING LOADING AFTER OPENING THE VIAL ON (B)(6) 2023. ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE THAT DID NOT PERFORM AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212228 ↗
• MalfunctionSep 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2023 A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -13.50 DIOPTER TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENTS LEFT EYE (OS). THE LENS WAS INTRAOPERATIVELY REMOVED WITHOUT PATIENT INJURY. ON (B)(6) 2023 A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED. IN THE REPORTERS OPINION THE CAUSE OF THE EVENT IS THE DEVICE, " LENS GOT STUCK BETWEEN THE ROD AND THE CARTRIDGE" WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814744 ↗
• InjuryJun 14, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -13.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. THE SURGEON REPOSITIONED THE LENS ON (B)(6) 2023 AND THIS RESOLVED THE PROBLEM. IT WAS ADDITIONALLY NOTED "THE DOCTOR ROTATED THE LENS 90 DEGREES VAULT IS OK". THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131350 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.