EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-5.5/2.5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311311934), received between Mar 16, 2023 and Sep 24, 2024 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE IMPLANT OF AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE, TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED BILATERALLY. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. PER THE REPORTER THIS OCCURRED IN THE SAME SURGERY ROOM WITH DIFFERENT INSTRUMENT SETS. INFORMATION ABOUT OVD AND THE LENS DELIVERY SYSTEM WERE NOT PROVIDED. INTRACAMERAL MOXIFLOXACIN HYDROCHLORIDE/ LOTEPREDNOL ETABONATE / OFLOXACIN WERE USED. DIAGNOSTIC CULTURE WAS NOT PERFORMED. THE PATIENT WAS PRESCRIBED STANDARD STEROID AND MOXIFLOXACIN DROPS FOR TWO WEEKS AFTER SURGERY. THE LENS WAS REMOVED, AND THE PROBLEM WAS RESOLVED. PER POST-OP VISIT, PATIENT CONDITION WAS BCVA: 20/20; IOP: 11 MMHG. THE REPORTER DOES NOT PROVIDE A CAUSE FOR THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. THERE ARE MULTIPLE 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: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20294367 ↗
• InjuryAug 22, 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. IN A SEPARATE VISIT, THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS OF SHORTER LENGTH. THE PROBLEM WAS RESOLVED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034926 ↗
• InjuryDec 15, 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 -5.50/+2.5/090 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT. THAT SAME DAY IN A SEPARATE SURGERY, A SHORTER LENGTH LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336981 ↗
• InjuryMay 31, 2023Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2; -5.50/+2.50/0 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 17035342 ↗
• InjuryApr 11, 2023Inadequacy of Device Shape and/or Size; No Apparent Adverse Event; Inadequacy of Device Shape and/or Size; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VTICM5_13.2, -5.5/2.0/082 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY WITH A SHORTER LENGTH LENS ON (B)(6) 2023 FROM PATIENT'S RIGHT EYE (OD) DUE TO EXCESSIVE VAULT.THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713988 ↗
• InjuryMar 16, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem; Misfocusing; Inadequacy of Device Shape and/or Size; Optical Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VTICM5_13.2 IMPLANTABLE COLLAMER LENS, -05.50/+2.5/095 (SPHERE/CYLINDER/AXIS), INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO EXCESSIVE VAULTING, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, GLARE/HALOES AND BLURRED VISION. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED.

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

  MAUDE report 16555168 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-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-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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.