EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-7.5/2.0) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311311699), received between Nov 4, 2022 and Jun 17, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 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 REDUCTION OF IRIDOCORNEAL ANGLES. IN A SEPARATE SURGERY THE LENS WAS EXPLANTED. AT A LATER DATE A REPLACEMENT LENS OF A SHORTER LENGTH WAS IMPLANTED AND PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25540772 ↗
• InjuryDec 19, 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 LENS ROTATION WITHOUT REPOSITIONING. THE LENS WAS LATER EXCHANGED FOR A LONGER LENGTH LENS IMPLANTED VERTICALLY AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850417 ↗
• InjuryAug 22, 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 ON (B)(6) 2025, INTO THE PATIENT'S LEFT EYE (OS) THE PATIENT EXPERIENCED ENDOPHTHALMITIS, PIGMENT DISPERSION AND MEDICATION WAS PRESCRIBED. REPORTEDLY, "ASEPETIC INFLAMMATION WITH PIGMENT CELL DEPOSITION". THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. DIAGNOSTICS AND TREATMENT WAS PERFORMED BUT THE RESULTS OF THESE WERE NOT PROVIDED. THE LENS REMAINS IMPLANTED. PER LAST VISIT ON (B)(6) 2025, BCVA WAS RECORDED AS 20/20(PRE-OP BCVA NOT PROVIDED) WITH A VAULT OF 415 M AND AN IOP OF 13 MMHG. 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. THIS REPORT IS PART OF A BOLUS SUBMISSION OF INDIVIDUALLY REPORTED EVENTS IDENTIFIED DURING A RETROSPECTIVE REVIEW BY THE CUSTOMER COVERING A SIX-MONTH PERIOD. EACH CASE IS SUBMITTED SEPARATELY AND DOES

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

  MAUDE report 22879567 ↗
• InjuryMay 17, 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 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.50/2.0/180 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXPLANTED DUE TO REFRACTIVE SURPRISE. ON (B)(6) 2024 A REPLACEMENT LENS OF A DIFFERENT MODEL/SAME LENGTH WAS IMPLANTED. THE PROBLEM WAS NOT RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE - "WRONG AXIS IN THE TICL".

  Patient problems: Blurred Vision

  MAUDE report 19347511 ↗
• InjuryJan 31, 2024Inadequacy 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 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.5/2.0/074 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615752 ↗
• InjuryNov 4, 2022Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size; Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -7.50/2.0/103 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE PATIENT EXPERIENCED EXCESSIVE VAULTING AND BLURRED VISION. ON (B)(6) 2022 THE LENS WAS EXPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 15728310 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-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.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.