EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841542119146), received between Oct 20, 2022 and Oct 23, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Misfocusing” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Sep 29, 2023Class IIOpen, Classified

   Their is a potential that intraocular implant devices may not meet specifications.

   Z-0465-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 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 LOW VAULT, BLURRED VISION AND HALOS/CIRCLES IN VISION AT NIGHT. DUE TO LOW VAULT, THE LENS WAS EXPLANTED. CAUSE OF EVENT WAS REPORTED AS DEVICE/PATIENT-RELATED FACTOR; PATIENT HAD HALO INTOLERANCE AND LOSS OF NEAR VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Blurred Vision; Halo

  MAUDE report 20515978 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LENS POWER ISSUE. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE. 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 19697725 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6; -08.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. IT WAS REPORTED THAT THE LENS WAS EXPLANTED AND A REPLACEMENT LENS WAS IMPLANTED. 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 19213602 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON IMPLANTED A 12.6MM VICM5 -8.00D IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. DURING LENS IMPLANTATION THE ICL WAS MANUALLY EXTRACTED WITH FORCEPS AND RELOADED INTO A NEW INJECTOR FOLLOWED BY SUCCESSFUL PLACEMENT. THE SURGEON REPORTS DURING IMPLANTATION THE ICL MADE CONTACT WITH THE IRIS AGGRESSIVELY AND POSSIBLY WITH THE ADJACENT CONJUNCTIVA. ON DAY 3 AN ABOVE NORMAL INFLAMMATION WAS NOTED WITH PRESENTATION OF IRITIS AND HYPOPYON ALONG WITH REPORT OF TASS. ON (B)(6) 2024 AN ANTERIOR CHAMBER TAP WAS PERFORMED WITH FLUID SENT FOR BACTERIAL CULTURE. ON THE SAME DAY INTRAVITREAL ANTIBIOTICS OF VANCOMYCIN AND CEFTAZIDIME WERE GIVEN BY THE RETINAL SPECIALIST. THE REPORTER DID NOT PROVIDE IDENTIFICATION OF MICROORGANISMS. BY (B)(6) 2024, THE PATIENT WAS NOTED AS "RECOVERED COMPLETELY" WITH HYPOPYON RESOLVED. ATROPINE WAS GIVEN FOR DILATION AND VISION REPORTEDLY IMPROVED TO 20/40+1. THE LENS REMAINS IMPLANTED. THE REPORTER STATES THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Iritis; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18991248 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS WITH A DIOPTER OF -8.0 WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND A SMALLER LENGTH LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162242 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6; -08.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). IT WAS INDICATED THAT THE LENS WAS EXPLANTED AND REPLACED WITH A LONGER LENGTH LENS. 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 16660284 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6; -08.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD). IT WAS INDICATED THAT ON (B)(6) 2022 THE LENS WAS EXPLANTED AND REPLACED WITH A LONGER LENGTH LENS. 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 16659626 ↗
• InjuryNov 9, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -08.00 DIOPTER. THE BACKUP LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15761892 ↗
• InjuryOct 20, 2022Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6, -8.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. IT WAS REPORTED THAT LIMBAL RELAXING INCISIONS (LRIS) WERE MADE TO REDUCE ASTIGMATISM BUT IT DID NOT REDUCE THE EXPECTED AMOUNT. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A TORIC LENS TO ADDRESS THE ASTIGMATISM (HIGH CYLINDER POWER) AND THE PROBLEM RESOLVED. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS USER ERROR, PRODUCT DID NOT FAIL TO PERFORM AS INTENDED.

  Patient problems: Blurred Vision

  MAUDE report 15640127 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.