EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-11.5/2.5) (REF VTICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311312054), received between Oct 21, 2024 and Sep 1, 2026 — classified as 5 injuries, 1 malfunction.

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.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  The reporter indicated that following an implantable collamer lens (ICL) implantation procedure, the patient experienced excessive vault and elevated IOP. The lens remains implanted. Final patient status is unknown. The cause of the event was reported as device. 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 50548190 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED INFLAMMATION. REPORTEDLY, 'RIGHT EYE IS FAIRLY QUIET WITH MINIMAL CELLULAR REACTION ICL IN PLACE'. THE LENS REMAINS IMPLANTED. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 24878581 ↗
• InjurySep 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 LENS ROTATION NOT ASSOCIATED TO A LOW VAULT. DUE TO LENS ROTATION NOT ASSOCIATED TO A LOW VAULT, THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE IS UNKNOWN.

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

  MAUDE report 22941317 ↗
• 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 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Endophthalmitis; Inflammation

  MAUDE report 22890242 ↗
• InjuryNov 19, 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 REFRACTIVE SURPRISE. THE LENS WAS LATER REMOVED AND REPLACED FOR A SAME SIZE DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS 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.

  Patient problems: Blurred Vision

  MAUDE report 20719786 ↗
• MalfunctionOct 21, 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 LENS ROTATION NOT ASSOCAITED TO A LOW VAULT. LENS REMAINS IMPLANTED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495046 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.