EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00840311300969), received between May 19, 2023 and Jun 11, 2026 — classified as 13 injuries, 11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING AND ELEVATED IOP. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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: Intraocular Pressure Increased

  MAUDE report 25479483 ↗
• InjuryJun 1, 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 SURPRISE. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 25351938 ↗
• 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 A LOW VAULT, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, REFRACTIVE SURPRISE AND OVER/ UNDER CORRECTION. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A LONGER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS A PATIENT RELATED FACTOR.

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

  MAUDE report 24335739 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED RETINAL DETACHMENT. PNEUMATIC RETINOPATHY WAS PERFORMED BUT REDETACHED. PHACO + VITRECTOMY WAS PERFORMED. REPORTEDLY, "SURGERY WAS PERFORMED WITH STANDARD PROCEDURE SMOOTHLY. POD1 WITH GOOD WOUND HEALING, NORMAL IOP, NORMAL VAULT HEIGHT. PATIENT WAS FOUND TO HAVE SUPERIOR RETINAL DETACHMENT IN RIGHT EYE. PNEUMATIC RETINOPATHY WAS DONE AND ATTACHED SUPERIORLY. HOWEVER, THERE WAS DETACHMENT INFERIORLY WITH MULTIPLE BREAKS 180 DEGREES FROM ORIGINAL BREAK. THE RETINAL SURGEON REMOVED HER ICL AND DID A PHACO VITRECTOMY, CURRENTLY SHE IS LP IN THAT EYE." IN A SEPARATE SURGERY THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR.

  Patient problems: Retinal Detachment

  MAUDE report 24215015 ↗
• MalfunctionOct 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED AN IMPLANTABLE COLLAMER LENS (ICL) WAS IMPLANTED UPSIDE DOWN. THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REPLACED. THE LENS TORE DURING REMOVAL. REPLACEMENT LENS WAS IMPLANTED. THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20378057 ↗
• InjuryAug 22, 2024Adverse 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 REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 20041222 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT FROM A FACILITY ON (B)(6) 2024 INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, TASS WAS DIAGNOSED IN THE PATIENT'S RIGHT EYE (OD). THE LIOLI INJECTOR DELIVERY SYSTEM WAS USED. ADDITIONAL INFORMATION STATED PATIENT VA WAS 20/15 AND WAS HAPPY AND WELL. THE REPORTER STATED THAT THE SURGEON THOUGHT MOST LIKELY CAUSE WAS THE STERILIZATION PROCESS LIKELY WITH THE MANIPULATOR. THE LATEST INFORMATION OBTAINED ON (B)(6) 2024 INDICATED THE PATIENT IS DOING BETTER AND NO EXPLANT WAS NEEDED. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19929841 ↗
• InjuryJul 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. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. THE PROBLEM WAS NOT RESOLVED. FOLLOW-UP TREATMENT PLANNED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 2 TOTAL REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804479 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM VICM5 -11.5D IMPLANTABLE COLLAMER LENS INTO THE PATIENT`S RIGHT EYE(OD) ON (B)(6) 2024.MSI INJECTOR SYSTEM AND PROVISC AS VISCOSURGICAL DEVICE(OVD) WERE USED DURING SURGERY. CLINICAL SIGNS OF ENDOPHTHALMITIS ("HYPOPYON" AND "CONJUNCTIVAL HYPEREMIA") WERE OBSERVED ON (B)(6) 2024. HUMOR AQUEOUS WAS SENT FOR ANALYSIS AND RESULTS WERE PENDING. ADDITIONAL TREATMENT PERFORMED INCLUDED INTRAOCULAR INJECTION OF STEROID AND ANTIBIOTIC. AS OF (B)(6) 2024 THE PATIENT STATUS OF THE EYE WAS REPORTED TO IMPROVE "ABSENCE OF HYPOPYON" AND "SLIGHT IMPROVEMENT OF VISUS." THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.THE LENS REMAINS IMPLANTED.

  Patient problems: Endophthalmitis

  MAUDE report 19645837 ↗
• MalfunctionJun 1, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.50 AS AN EXCHANGE LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024 TO RESOLVE THE LOW VAULT. REPORTEDLY, "PERSISTS LOW VAULT. PATIENT IN TREATMENT OF OCULAR HYPERTENSION. " THE LENS REMAINED IMPLANTED. THE PROBLEM WAS NOT RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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 19442395 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS -11.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON 29-JAN-2024 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE EXCHANGE RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327167 ↗
• MalfunctionApr 7, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -11.50 DIOPTER, DURING THE SAME SURGERY DUE TO THE LENS WAS STUCK IN CARTRIDGE OR INJECTION SYSTEM AND TORE/BROKE DURING INJECTION/DELIVERYINTO THE PATIENTS RIGHT EYE (OD). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/ENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056923 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -11.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. OBSERVATION OF LENS DISLOCAION/SUBLUXATION AND DECREASE VISUAL ACUITY WAS REPORTED. LENS REMAINS IMPLANTED. CAUSE OF EVENT WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 18916652 ↗
• MalfunctionJan 30, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -11.5 DIOPTER LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED FROM THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023, DUE TO A LENS TEAR/BREAK DURING INJECTION/DELIVERY. ON (B)(6) 2023, A BACK UP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611049 ↗
• MalfunctionJan 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2; -11.5 DIOPTER IMPLANTABLE COLLAMER LENS HAD TORE DURING LOADING. THE LENS WAS NOT IMPLANTED. THIS OCCURRED ON (B)(6) 2023. ON (B)(6) 2023 A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479798 ↗
• MalfunctionDec 18, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2023 A 13.2MM, VICM5_13.2, -11.50 DIOPTER, IMPLANTABLE COLLAMER LENS GOT STUCK IN CARTRIDGE OR INJECTION SYSTEM AND TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY WITH NO PATIENT INJURY AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352498 ↗
• MalfunctionDec 4, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2. -11.50 DIOPTER IMPLANTABLE COLLAMER LENS LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT(LENS TOUCHED THE EYE). NO PATIENT INJURY. THE LENS WAS EXCHANGED WITH A SAME LENGTH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258199 ↗
• MalfunctionNov 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, -11.50 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6). 2023. EXCESSIVE VAULT WAS OBSERVED. ON (B)(6).2023 PATIENTS VAULT WAS 1 CCT. THERE FOR NO EXCHANGE IS REQUIRED. PROBLEM RESOLVED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210957 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VTICMO13.2 IMPLANTABLE COLLAMER LENS OF A -14.0/3.0/91 (SPHERE/CYLINDER/AXIS) LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED ON (B)(6) 2023 DUE TO A LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE PATIENT'S LEFT EYE (OS). ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THERE WAS PATIENT CONTACT AND PATIENT INJURY. REPORTEDLY, "LENS GOT STUCKED IN THE PLUNGER." STATUS OF THE EYE IS QUIET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052033 ↗
• InjuryJul 18, 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 -11.50 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, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES AND BLURRED VISION. THIS EXCHANGE RESOLVED THE PROBLEM. THE REPORTER STATES THE CAUSE OF THIS EVENT IS UNKNOWN. FOR CAUSE DETAILS THE REPORTER STATES " SULCUS TO SULCUS SMALLER THAN THE ESTIMATE".

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

  MAUDE report 17343354 ↗
• InjuryJul 18, 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 -11.50 DIOPTER WAS IMPLANTED 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, ANGLE CLOSURE WITH ELEVATED IOP (INTRAOCULAR PRESSURE) AND BLURRED VISION. THIS EXCHANGE RESOLVED THE PROBLEM. THE REPORTER STATES THE CAUSE OF THIS EVENT IS UNKNOWN. FOR CAUSE DETAILS THE REPORTER STATES " SULCUS TO SULCUS SMALLER THAN THE ESTIMATE".

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

  MAUDE report 17343177 ↗
• MalfunctionJul 5, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 13.2MM VICM5 13.2 IMPLANTABLE COLLAMER LENS, -11.50 DIOPTER, TORE DURING LOADING AND THERE WAS NO PATIENT CONTACT. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262262 ↗
• MalfunctionMay 19, 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 -11.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT WAS OBSERVED, LENS REMAINS IMPLANTED. PER UPDATED INFORMATION SURGEON DECIDED TO LEAVE LENS IN SITU (IN PLACE) AND MONITOR AS THE VAULT IS NOT CAUSING ANY ISSUES. PATIENT HAS OPEN ANGLES AND IS ASYMPTOMATIC. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963130 ↗
• MalfunctionMay 19, 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 -11.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. EXCESSIVE VAULT WAS OBSERVED, LENS REMAINS IMPLANTED. PER UPDATED INFORMATION SURGEON DECIDED TO LEAVE LENS IN SITU (IN PLACE) AND MONITOR AS THE VAULT IS NOT CAUSING ANY ISSUES. PATIENT HAS OPEN ANGLES AND IS ASYMPTOMATIC. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959725 ↗

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