EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-4.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841542119306), received between Jan 12, 2023 and Nov 21, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 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 EXCESSIVE VAULT, HEADACHE AND NARROW ANGLES. DUE TO EXCESSIVE VAULT, HEADACHE AND NARROW ANGLES, THE LENS WAS EXPLANTED AND REPLACED FOR A SHORTER LENGTH LENS. THIS RESOLVED THE PROBLEM. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20752432 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. BASELINE IOP WAS 13-15 AND AFTER 6MONTHS BASELINE IOP IS AROUND 22-24. EYE DROPS PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 19509346 ↗
• MalfunctionJul 7, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2, -04.50 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED, REMOVED, AND REPLACED WITH A SAME LENGTH DIFFERENT POWER LENS INTRAOPERATIVELY ON (B)(6) 2023 FROM PATIENT'S LEFT EYE (OS) DUE TO WRONG LENS POWER BEING IMPLANTED. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS OTHER, ROOT CAUSE TO BE DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279035 ↗
• InjuryJun 23, 2023Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Misfocusing; Off-Label Use; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -4.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE SURGEON REPORTS THERE IS EXCESSIVE VAULTING AND REFRACTIVE SURPRISE. LENS REMAINS IMPLANTED. PROBLEM IS NOT RESOLVED.

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

  MAUDE report 17194710 ↗
• MalfunctionMay 25, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -4.50 DIOPTER INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. REPORTEDLY, "ANTERIOR SEGMENT OCT VAULTS WERE 1.11MM OD AND 1.35MM OS ON POD#1. POST-OP MONTH 1 VAULTS WERE 1.04MM OD AND 1.30MM OS. VISION IS 20/15 UNCORRECTED OU AND GONIO WAS SUP/INF: (B/C)C/D20S; N/T:(B)B/C15S. SHE JUST FOUND OUT SHE IS PREGNANT, SO WE ARE NOT PLANNING TO DO AN EXCHANGE UNTIL AFTER COMPLETION OF PREGNANCY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008321 ↗
• InjuryJan 12, 2023Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS REMOVED DUE TO HALOS.

  Patient problems: Halo

  MAUDE report 16152675 ↗

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-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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.