EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-10.5/2.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840311312030), received between Sep 12, 2023 and Oct 20, 2025 — classified as 13 injuries, 2 malfunctions.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 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. THE LENS WAS REPOSITIONED, BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH THE SAME MODEL/LENGTH, DIFFERENT POWER AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342675 ↗
• InjuryAug 25, 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 ENDOPHTHALMITIS, "ASEPTIC INFLAMMATION WITH PIGMENT CELL DEPOSITION," DIAGNOSTIC CULTURES AND TREATMENT WERE PERFORMED, PUPIL IMPAIRMENT. THE LENS REMAINS IMPLANTED, AND MEDICATION TREATMENT WAS ADMINISTERED. THE CAUSE OF THE EVENT WAS REPORTED UNKNOWN. 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 NOT INDICATE A TEMPORAL CLUSTER. THIS TIMELINE ALSO HIGHLIGHTS A DELAYED ONSET OF THE BOLUS REPORTED EVENTS RELATIVE TO THE PROCEDURE DATE (AVERAGE: 26 DAYS, RANGE:17-35 DAYS, AS WELL AS A DELAY IN REPORTING DUE TO RETROSPECTIVE CASE IDENTIFICATION. THIS REPORT IS 2 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Endophthalmitis; Inflammation

  MAUDE report 22890243 ↗
• InjuryAug 21, 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 REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT DIOPTER LENS AND THE PROBLEM RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 22868213 ↗
• InjuryAug 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 ELEVATED IOP, UVEITIS/IRITIS, PIGMENT DISPERSION. REPORTEDLY, "CILIARY BODY CYST CAUSING PIGMENT DISPERSION". THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Uveitis

  MAUDE report 22841858 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED LOW VAULT WITH LENS ROTATION, AND BLURRED VISION. THE LENS WAS EXPLANTED AND REPLACED WITH A LONGER LENGTH LENS BUT THIS DID NOT RESOLVE THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. 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: Blurred Vision

  MAUDE report 22795286 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CH A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 21400280 ↗
• InjuryDec 12, 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 EXCESSIVE VAULT. THE LENS WAS LATER EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919232 ↗
• InjuryDec 9, 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 SWELLING OF CORNEA. LENS REMAINS IMPLANTED. THE PROBLEM WAS NOT RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 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: Corneal Edema

  MAUDE report 20879309 ↗
• MalfunctionNov 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. THE LENS REMAINS IMPLANTED. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604632 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -10.5/2.5/90 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON AN UNKNOWN DATE. REPORTEDLY THERE WAS A STEROID RESPONSE AND ELEVATED IOP. ADDITIONAL DETAILS THE PATIENT IS STABLE AND DISCONTINUING MEDICATION (B)(6) 2024. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19668915 ↗
• MalfunctionFeb 27, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2. -10.5/2.5/089 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS FOR THE PATIENT'S RIGHT EYE (OD) TORE, BROKE DURING INJECTION, DELIVERY INTO THE EYE ON (B)(6) 2023. THERE WAS NO PATIENT CONTACT. NO PATIENT INJURY. THE BACK UP LENS WAS IMPLANTED ON (B)(6) 2023. THIS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788740 ↗
• InjuryJan 14, 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 -10.5/+2.5/090 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. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509887 ↗
• InjuryDec 9, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VTICM5 13.2 IMPLANTABLE COLLAMER LENS OF -10.50/2.5/086 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND ELEVATED IOP. THE EXCHANGE RESOLVED THE PROBLEM. CAUSE REPORTED AS UNKNOWN.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 18298068 ↗
• InjuryOct 25, 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; -10.50/+2.50/111 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT EXPERIENCED LENS OPACITY (CORTICAL) ASSESSED ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND REPLACED WITH A CATARACT LENS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Cataract

  MAUDE report 18007848 ↗
• InjurySep 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 -10.5/+2.5/131 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT AND THIS RESOLVED THE PROBLEM. CAUSE REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733446 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.
• 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.