EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-7.0) (REF VICM5 12.1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840311300211), received between Apr 19, 2024 and Sep 29, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Blurred Vision

  MAUDE report 50940917 ↗
• InjuryJul 27, 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 change over time. In a separate surgery the lens was exchanged with a longer length, different power and problem was resolved. The cause of the event was reported as unknown. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 50047723 ↗
• InjuryAug 20, 2025Adverse 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 HALOES. THE LENS WAS EXPLANTED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo

  MAUDE report 22847124 ↗
• InjuryAug 20, 2025Adverse 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 HALOES. THE LENS WAS EXPLANTED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo

  MAUDE report 22847123 ↗
• InjuryFeb 6, 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 A REFRACTIVE SURPRISE. DUE TO THE REFRACTIVE SURPRISE, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A SAME LENGTH BUT DIFFERENT MODEL AND POWER LENS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21326494 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS OF DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 21090838 ↗
• InjurySep 27, 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 REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS. THE PROBLEM WAS RESOLVED. 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. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 20327875 ↗
• MalfunctionSep 16, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT. THE LENS WAS REMOVED AND REPLACED WITHIN THE SAME SURGERY FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233387 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON IMPLANTED A 12.1MM VICM5 -07.00D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN AND THE MSI INJECTOR DELIVERY SYSTEM. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS OBSERVED AND PER REPORTER, NO DIAGNOSTICS WERE PERFORMED. TREATMENT INCLUDED: DEXAMETHASONE SUBCONJUNCTIVAL INJ, METHYLPREDNISOLONE SODIUM SUCCINATE IV, PREDNISOLONE 4 TABS 1W PO, BETAMETHASONE VALERATE/ GENTAMICIN SULFATE OPHTHALMIC DROPS FREQUENTLY, BRONUCK QID, VEGAMOX QID AND ATROPINE TID. BY DAY 6, THE BCVA & UCVA WERE 20/17, IOP 14MMHG, AND ANTERIOR CHAMBER EMPYEMA IMPROVED. THE LENS REMAINS IMPLANTED WITH THE ISSUE RESOLVED. IN THE REPORTER'S OPINION, THE CAUSE OF THE EVENT WAS AN "POSSIBLE ALLERGIC REACTION TO COLLAMER". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19531476 ↗
• InjuryApr 20, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.1MM VICM5 12.1 IMPLANTABLE COLLAMER LENS OF -7.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. IT IS ALLEGED THAT THE LENS WAS NOT THE SAME POWER AS INDICATED ON THE LABEL "WRONG LABELING". ON (B)(6) 2024 THE LENS WAS EXPLANTED AND A REPLACEMENT LENS OF THE SAME MODEL/SIZE AND POWER WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE REPLACEMENT LENS RESOLVED THE PROBLEM. CAUSE REPORTED AS DEVICE.

  Patient problems: Visual Disturbances

  MAUDE report 19149713 ↗
• MalfunctionApr 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.1MM VICM5 12.1 IMPLANTABLE COLLAMER LENS OF -7.00 DIOPTER LENS HAD A TEAR/BREAK DURING LOADING. THIS OCCURRED ON (B)(6) 2023. THE LENS WAS NOT IMPLANTED. ON (B)(6) 2023 A REPLACEMENT LENS OF THE SAME MODEL;/SIZE AND DIOPTER WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149643 ↗

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-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-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.