EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-11.5/1.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840311311491), received between Feb 10, 2023 and Apr 2, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 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 LENS ROTATION. THE LENS WAS EXPLANTED AND REPLACED WITH BACKUP LENS. 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. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769864 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ENDOPHTHALMITIS, HYPOPYON, AND LOSS OF BCVA. THE LENS WAS EXPLANTED, ANTIBIOTIC MEDICATION WAS ADMINISTERED, AND THE PROBLEM WAS RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Blurred Vision; Endophthalmitis

  MAUDE report 24584868 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT, ELEVATED IOP AND SIGNIFICANT SHALLOWING ON ANTERIOR CHAMBER. THE LENS REMAINS IMPLANTED. FINAL PATIENT STATUS IS UNKNOWN. 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. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 23694650 ↗
• InjuryApr 4, 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 -11.5/1.5/164 (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, AND GLARE/HALOES. ON (B)(6) 2024 A REPLACEMENT LENS OF A DIFFERENT MODEL/ SHORTER LENGTH WAS IMPLANTED. REPORTEDLY, "VAULT HEIGHT SATISFACTORY AFTER ICL EXCHANGE." THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS OTHER DUE TO 'VAULT HEIGHT TOO HIGH. ICL OVERSIZED.'

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

  MAUDE report 19047640 ↗
• InjuryDec 12, 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 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.5/+1.5/094 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. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311790 ↗
• InjuryNov 27, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -11.50/+1.5/102 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED LOW VAULTING WITH ROTATION; THE SURGEON PERFORMED ANTERIOR CHAMBER IRRIGATION/EVACUATION OF VISCO/FLUIDS; AND INTRAOCULAR INJECTION - APROKAM (CEFUROXIME). IT WAS THEN INDICATED THAT ON (B)(6) 2023 THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212738 ↗
• InjuryNov 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 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.5/+1.5/100 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180595 ↗
• InjuryNov 14, 2023Adverse 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; -11.50/+1.5/072 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. INTRAOPERATIVELY THE LENS WAS REMOVED. IT WAS NOTED THAT "OD PAIN EYELID EDEMA - INFLAMMATION DESPITE ANTI-INFLAMMATORY EYE DROPS FOR 3 DAYS - TOBRADEX = DEXAMETHASONE AND TOBRAMYCINE. LENS REMAINS IMPLANTED.

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

  MAUDE report 18136620 ↗
• MalfunctionMar 22, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE REPORTER INDICATED THAT ON (B)(6) 2023, A 13.2MM VTICM513.2 IMPLANTABLE COLLAMER LENS OF -1.50/1.5/85 (SPHERE/CYLINDER/AXIS) LENS TORE/BREAK INJECTION/DELIVERY INTO THE RIGHT EYE (OD). THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED. CAUSE OF THE EVENT WAS REPORTED AS USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595252 ↗
• InjuryFeb 10, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -11.50/+1.5/093 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE SURGEON REPORTS LENS WAS IMPLANTED UPSIDE DOWN. ON (B)(6) 2022 THE LENS WAS EXCHANGED WITH A SAME LENGTH LENS AND THIS RESOLVED THE PROBLEM. THERE WAS NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358880 ↗

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