EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-10.0/1.5) (REF VTICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00840311308101), received between Feb 21, 2023 and May 26, 2026 — classified as 18 injuries, 1 malfunction.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. 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: Blurred Vision

  MAUDE report 25293091 ↗
• InjuryNov 12, 2025Adverse 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 LENS ROTATION. THE LENS WAS REPOSITIONED BUT THAT DID NOT RESOLVE THE PROBLEM. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A LONGER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538455 ↗
• InjurySep 17, 2025Adverse 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 LENS ROTATION. THE LENS WAS LATER EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS A PATIENT-RELATED-FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080749 ↗
• InjuryJul 11, 2025Adverse 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 A ELEVATED IOP. MEDICATION WAS PRESCRIBED. REPORTEDLY, "AFTER 15 DAYS POSTOPERATIVELY IOP HAD A SLIGHT INCREASE TO 20. DOCTOR PRESCRIBED EYE DROPS, WITH MEDICATION CONTROL IOP IS 14" AND "DOCTOR OBSERVED SLIGHT PIGMENTATION 15 DAYS AFTER SURGERY." THE LENS REMAINS IMPLANTED. IT WAS LATER REPORTED, "WE RECEIVED MEDICAL RECOMMENDATION FROM MEDICAL AFFAIRS, THE DOCTOR FOLLOW THEM AND THE PATIENT IS FINE". 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 22481761 ↗
• InjuryDec 9, 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 WITHOUT ROTATION, REFRACTIVE SURPRISE, AND BLURRED VISION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20887849 ↗
• InjuryNov 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 EXCESSIVE VAULT. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761660 ↗
• InjuryOct 21, 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 SIGNIFICANT REDUCTION IN IRIDOCORNEAL ANGLES. LENS REMAINS IMPLANTED. IOP AND VA IS STABLE. NO HEADACHES OR PAIN ASSOCIATED. DIAMOX WAS GIVEN TO PATIENT AFTER SURGERY. CAUSE OF EVENT WAS REPORTED AS DEVICE.

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

  MAUDE report 20494701 ↗
• InjuryOct 14, 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 LENS FLIPPED. DUE TO LENS FLIP, THE LENS WAS REMOVED AND REPLACED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20447040 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF A 12.6MM VTICM5 -10.00/+1.50/070 LENS, THE PATIENT EXPERIENCED PAIN AND TASS WAS DIAGNOSED IN THE LEFT EYE (OS). THE PATIENT UNDERWENT BILATERAL SEQUENTIAL ICL IMPLANTATION. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN VISCOELASTIC, LIDOCAINE, ADRENALINE, AND THE MSI INJECTOR SYSTEM. ON DAY 4, UCVA OF 20/13, AND ANTERIOR CHAMBER / INTRAVITREAL INFLAMMATION (CELL AND FIBRIN) AND "HAIR-LIKE" HYPEREMIA WERE PRESENT. REPORTEDLY, NO OCULAR LIPID OR ANTERIOR CHAMBER PUS. HOURLY STEROIDS AND ANTIBIOTICS WERE GIVEN. THE LENS REMAINS IMPLANTED. THE PROBLEM IS NOT RESOLVED WITH CAUSE OF EVENT REPORTED AS UNKNOWN.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19960753 ↗
• InjuryMay 9, 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 VTICM5 -10.00/+1.50/081 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. INFORMATION ABOUT CONCOMITANT PRODUCTS USED INCLUDING OVD AND DELIVERY SYSTEM WERE NOT PROVIDED. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. PER THE LAST REPORT DATED APR-17-2024, NO INFORMATION IS PROVIDED THAT THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED. NO LOSS OF VISUAL ACUITY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19276560 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON IMPLANTED A 12.6MM -10.00/+1.50/091 VTICM5 IMPLANTABLE COLLAMER LENS INTO A 47YO PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN VISCOELASTIC, AND THE MSI INJECTOR SYSTEM. INTRACAMERAL ADRENALINE, ACETYLCHOLINE AND MOXIFLOXACIN WERE USED. IMMEDIATELY AFTER SURGERY, CASIA IMAGING SHOWED 0.9 CT WITH NO IOP PROBLEM. ONSET OF INFLAMMATION OCCURRED ON DAY 1 WITH "SWELLING AND PAIN" AND "DEPOSITS ON THE LENS". THE EYE WAS "MYDRIATIC" WITH IOP 37MMHG AND OCT IMAGING SHOWING 1.5 CT. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS SUSPECTED. MANNITOL INFUSION WAS GIVEN ALONG WITH MIOTICS (SANPILO); HOWEVER, MYDRIASIS PERSISTED. ON DAY 2, THE IOP LOWERED TO 13MMHG, AND ADHESIONS PRESENTED ON THE ANTERIOR SURFACE OF THE LENS. INCREASED FREQUENCY OF ANTIBIOTIC STEROID DROPS WERE PRESCRIBED AND ADHESIONS AND IOP CONTINUED TO IMPROVE. THE LAST REPORT ON 10-APR-2024, SHOWED BY DAY 5, THE BCVA WAS 20/20, UCVA: 20/29, IOP 9.6MMHG, VAULT 2.32CT. ANTERIOR SEGMENT IMAGES PROVIDED BY THE REPORTER SHOW STELLATE PATTERN OPACITIES. THE REPORT STATED THAT CAUSE OF THE EVENT WAS "OTHER" AND IT WAS NO

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19256077 ↗
• InjuryApr 15, 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 VTICM5 IMPLANTABLE COLLAMER LENS OF -10.00/+1.50/090 POWER (SPHERE/CYLINDER/AXIS) INTO THE PATIENT'S RIGHT EYE (OD) ON AN UNKNOWN DATE. REPORTEDLY, "PATIENT IS EXPERIENCING INFLAMMATION IN THE RIGHT EYE." TO THE BEST OF OUR KNOWLEDGE THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 19105572 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VTICM5_12.6; -10.00/1.5/090 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093844 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM5_12.6 IMPLANTABLE COLLAMER LENS OF -10.00/1.5/084 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6)2023 THE LENS WAS REMOVED DUE TO REFRACTIVE SURPRISE. A REPLACEMENT LENS OF DIFFERENT POWER WAS LATER IMPLANTED AND THE PROBLEM RESOLVED. " NORMAL, WITHOUT SIGNS AND SYMPTOMS" WAS REPORTED FOR STATUS OF THE EYE.

  Patient problems: Blurred Vision

  MAUDE report 18843029 ↗
• MalfunctionFeb 13, 2024Misfocusing; No Apparent Adverse Event; Misfocusing; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -10.0/1.5/91 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. REFRACTIVE SURPRISE WAS OBSERVED. REPORTEDLY, "THE VISION HAS BEEN GRADUALLY IMPROVING." THE PROBLEM HAS BEEN RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 18695938 ↗
• InjuryJan 5, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Optical Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Optical Problem

  THE REPORTER INDICATED THAT A 12.6MM VTICM512.6 IMPLANTABLE COLLAMER LENS OF -10.0/1.5/91 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT AND GLARE/HALOS WERE OBSERVED. CAUSE OF THE EVENT IS OTHER.

  Patient problems: Visual Disturbances

  MAUDE report 18456592 ↗
• InjuryNov 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM VTICM5 12.6 IMPLANTABLE COLLAMER LENS OF -10.00/1.5/080 (SPHERE/CYLINDER/AXIS) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. LENS ROTATION WAS OBSERVED. ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A SPHERICAL LENS MODEL OF THE SAME SIZE. THE REPLACEMENT LENS RESOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105875 ↗
• InjuryApr 17, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VTICM512.6, -10.0/1.5/084 (SPHERE/CYLINDER/AXIS), IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT ON (B)(6) 2023. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750652 ↗
• InjuryFeb 21, 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 VTICM5_12.6; -10/1.5/108 (SPHERE/CYLINDER/AXIS) IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6)2023; AS A REPLACEMENT LENS. THE PATIENT EXPERIENCED SIGNIFICANT REDUCTION OF ENDOTHELIAL CELL COUNT OR SIGNIFICANT ENDOTHELIAL CELL LOSS; AND CORNEAL ODEMA DUE TO THE PREVIOUS TRICKY EXCHANGE (CONSTRICTION OF PUPIL DURING PROCEDURE). IT WAS ADDITIONALLY NOTED THAT "VISION IS EXCELLENT THEREFORE SURGEON DOESN'T WANT TO REMOVE LENS SO IS GOING TO LEAVE IN SITU AND MONITOR PATIENT". PROBLEM IS REPORTED AS NOT RESOLVED.

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

  MAUDE report 16413617 ↗

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-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.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• 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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.