EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-12.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00840311300976), received between Apr 6, 2023 and Jun 9, 2026 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED OVER/UNDER CORRECTION. LENS EXCHANGED WITH DIFFERENT DIOPTER LENS. PROBLEM 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. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

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

  MAUDE report 25439027 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED AN OVER/UNDER CORRECTION. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A TORIC LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS 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

  MAUDE report 24569790 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED AN EXCESSIVE VAULT AND VISUAL DISTURBANCES. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS.

  Patient problems: Visual Disturbances

  MAUDE report 24337087 ↗
• MalfunctionSep 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FACILITY REPRESENTATIVE REPORTED DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS TORE DURING INJECTION/DELIVERY. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. THE PATIENT EXPERIENCED LENS DISLOCATION/ SUBLUXATION. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY. THE CAUSE OF THE EVENT WAS REPORTED AS DEVICE / USER ERROR/ UNKNOWN AND THE DEVICE FAILED TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "LOADING IS GOOD BUT AFTER INSERTING INSIDE THE EYE, THE LENS WAS BREAK IN". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20219033 ↗
• MalfunctionAug 23, 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 FACILITY REPRESENTATIVE REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LEN ROTATION NOT ASSOCIATED TO A LOW VAULT. PACHO-EMULSIFICATION AND IOL IMPLANTATION WAS PEFORMED. THE LENS WAS THEN INTRAOPERATIVELY REMOVED AND REPLACED FOR A REPLACEMENT LENS, AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. REPORTEDLY, "NO COMPLICATIONS FROM A REMOVING THE UPSIDE-DOWN ICL AND REPLACING," AND "ICL GOOD POSITION AND CORNEA CLEAR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055471 ↗
• MalfunctionAug 6, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE THE LENS FLIPPED. THE BACKUP LENS WAS USED. 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 19925105 ↗
• MalfunctionMar 15, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS. THE LENS WAS REPORTED AS HAVING A SIZING ISSUE AND REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914601 ↗
• InjuryDec 29, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -12.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422480 ↗
• InjuryDec 27, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_ 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -12.0 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401521 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.00 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO ENDOPHTHALMITIS WAS OBSERVED. DIAGNOSTICS OF BLOOD SAMPLING WAS PERFORMED. ANTERIOR CHAMBER CLEANING WAS PERFORMED. MEDICATION WAS ADMINISTERED (MELOTHENE CONJUNCTIVALIZATION INJECTION/ANTERIOR CHAMBER LAVAGE). VITREOUS SURGERY WAS PERFORMED AND AN IOL WAS IMPLANTED. POST-OP, VITREOUS RETINAL DETACHMENT TREATMENT, OIL INJECTION SURGERY, LASER TREATMENT GAS AND ANTERIOR CHAMBER LAVAGE. THE CAUSE OF THE EVENT WAS UNKNOWN. PATIENTS CURRENT CONDITION WAS VISUAL ACUITY AT HAND MOTION LEVEL, TREATMENT IS ON-GOING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Endophthalmitis; Retinal Detachment; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 18360972 ↗
• InjuryDec 11, 2023Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -12.0 DIOPTER WAS IMPLANTED UPSIDE DOWN INTO THE PATIENT'S RIGHT EYE (OD). LOW VAULT IS OBSERVED. REPORTEDLY, "PATIENT HAS LOST VISION BECAUSE THE LENS IS IMPLANTED UPSIDE DOWN." THE PROBLEM IS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18304971 ↗
• InjuryAug 25, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -12.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE. THE SURGEON NOTES THE LENS WAS IMPLANTED UPSIDE DOWN AND THE LENS WAS EXPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17628514 ↗
• MalfunctionAug 4, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -12.0 DIOPTER LENS TORE/BROKE DURING LOADING. THERE WAS PATIENT CONTACT. NO PATIENT INJURY WAS REPORTED. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS STATED AS OTHER. REPORTEDLY, "DEFECTIVE FORCEPS??"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461812 ↗
• MalfunctionJul 24, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -12.00 DIOPTER, TORE DURING LOADING AND WAS STUCK IN THE CARTRIDGE OR INJECTION SYSTEM. THERE WAS NO PATIENT CONTACT OR INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378741 ↗
• InjuryJul 12, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -12.0 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. IT WAS CONFIRMED THAT THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS ON (B)(6) 2023 DUE TO LOW VAULT. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313138 ↗
• MalfunctionMay 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  A USER HANDLING ISSUE/ERROR WITH A 13.2MM VICM5_13.2 -12.00 DIOPTER IMPLANTABLE COLLAMER LENS WAS REPORTED. 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 17005158 ↗
• InjuryApr 6, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -12.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES AND THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689139 ↗

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-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-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-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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.