EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00840311300839), received between Nov 29, 2022 and Aug 27, 2026 — classified as 23 injuries, 2 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported following an implantable collamer lens (ICL) implantation procedure, the patient experienced excessive vault with elevated IOP, pupil block., significant reduction of iridocorneal angles and shallowing of the AC and narrow angles. The lens exchanged for a shorter length lens and problem resolved. The cause of this event is the device.

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

  MAUDE report 50487996 ↗
• InjuryJul 30, 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, significant reduction of irido-corneal angle, shallow A/C. The lens was exchanged with a shorter length lens and the problem was resolved. The cause of the event was reported as unknown.

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

  MAUDE report 50093744 ↗
• InjuryJul 28, 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 refractive surprise. PRK was performed. Cause of the event was reported as other and noted "surgically induced cyl". Lens remains implanted.

  Patient problems: Blurred Vision

  MAUDE report 50063689 ↗
• InjuryJul 28, 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 refractive surprise. PRK was performed. Cause of the event was reported as other and noted "surgically induced cyl". Lens remains implanted.

  Patient problems: Blurred Vision

  MAUDE report 50063688 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED MILD TOXIC ANTERIOR SEGMENT SYNDROME. TREATMENT WAS PERFORMED AND PROBLEM WAS RESOLVED. LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS OTHER: TASS. 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. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 25379520 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED MILD TOXIC ANTERIOR SEGMENT SYNDROME. TREATMENT WAS PERFORMED AND PROBLEM RESOLVED. LENS REMAINS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS OTHER: TASS. 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. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 25379483 ↗
• InjuryFeb 24, 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 THE SAME MODEL, DIFFERENT POWER AND THE PROBLEM WAS RESOLVED. THE 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: Blurred Vision

  MAUDE report 24436914 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ELEVATED IOP. THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 24389889 ↗
• InjuryFeb 16, 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 REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT POWER LENS. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Blurred Vision

  MAUDE report 24352112 ↗
• InjuryNov 25, 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 REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SAME MODEL/SIZE BUT DIFFERENT POWER LENS. THE PROBLEM WAS RESOLVED. CAUSE 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: Blurred Vision

  MAUDE report 23649855 ↗
• InjuryJan 29, 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 OPACITY/ANTERIOR SUBCAPSULAR CATARACT. REPORTEDLY, "FIBRIN WAS OBSERVED OBSTRUCTING THE CENTRAL PORT, WHICH WAS RAISING INTRAOCULAR PRESSURE. IT WAS DECIDED TO APPLY A YAG LASER SHOT, WHICH ENDED UP IMPACTING THE LENS AND CAUSING A CATARACT." CAUSE OF THE EVENT WAS A USER ERROR. THE SURGEON WILL CONTINUE TO MONITOR IT'S PROGRESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270234 ↗
• InjuryDec 13, 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 REPLACEMENT LENS OF SHORTER LENGTH AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20932046 ↗
• MalfunctionDec 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) LENDS EXCHANGE PROCEDURE, THE PATIENT STILL EXPERIENCES A POSITIVE ASTIGMATISM; THIS REPLACEMENT LENS WAS IMPLANTED VERTICALLY SO THE VAULT IS BIGGER. THE LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. 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 20825424 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT A 13.2 MM VICM5 -5 D IMPLANTABLE COLLAMER LENS (ICL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN OVD AND THE MSI INJECTOR DELIVERY SYSTEM. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. ADDITIONAL DIAGNOSTICS WERE PERFORMED BUT CULTURES WERE NOT TAKEN. EYE DROPS AND ORAL MEDICATION WERE PRESCRIBED. AS OF ON (B)(6) 2024, ISSUES WERE REPORTED TO BE RESOLVED WITH PATIENT CONDITION: BCVA/UCVA:20/10; IOP:15MMHG; VAULT:509 M; "PIGMENTATION HAS IMPROVED CONSIDERABLY". THE LENS REMAINS IMPLANTED. IN THE REPORTER OPINION, THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 20700783 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON PERFORMED BILATERAL SEQUENTIAL SURGERY AND IMPLANTED A 13.2 VICM5; -5.0 D IMPLANTABLE COLLAMER LENS (ICL) INTO THE PATIENT`S LEFT EYE (OS) ON (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDED OPEGAN VISCOELASTIC AND THE MSI INJECTOR SYSTEM. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED BASED ON CLINICAL SIGNS. ADDITIONAL TREATMENT WAS PRESCRIBED. PER REPORT FROM 10-JUNE-2024, PATIENT CONDITION WAS BCVA:20/13; UCVA:20/20; IOP:14MMHG. INFLAMMATION WAS GRADED AS NOT SEVERE BUT PATIENT WAS UNDER CAREFUL OBSERVATION. ACCORDING TO THE REPORT THE CAUSE OF THE EVENT WAS UNKNOWN. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19754997 ↗
• 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 13.2 MM VICM5 -5.00D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024 AS A REPLACEMENT LENS FOR MDR 2023826-2024-02360. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE THE MSI INJECTOR DELIVERY SYSTEM. INFORMATION ON OVD TYPE WAS NOT PROVIDED. THE PATIENT HAD H/O BILATERAL IMPLANTATION OF ICLS. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED (OD ONLY) 1 MONTH EARLIER WITH THE INITIAL LENS IMPLANTED. DIAGNOSTIC TESTS WERE NOT PERFORMED. EXPLANT OF THE INITIAL LENS OCCURRED (7 WKS AFTER IMPLANTATION) FOLLOWED BY IMPLANTING THE REPLACEMENT ICL 1 MO LATER. BASED ON THE INFORMATION PROVIDED PERSISTENT INFLAMMATION WAS PRESENT DURING LENS IMPLANTATION AND IS UNRESOLVED. LAST REPORT ON DAY 6 STATES THE LENS REMAINS IMPLANTED AND THE PATIENT IS UNDER OBSERVATION. IN THE REPORTER'S OPINION THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19515589 ↗
• InjuryJun 11, 2024Adverse 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 -5.00D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL IMPLANTATION OF ICLS. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE PURIFIED SODIUM HYALURONATE VISCOELASTIC AND THE MSI INJECTOR SYSTEM. APPROXIMATELY 7 WEEKS LATER, TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED (OD ONLY) AND THE LENS WAS EXPLANTED. THE INFORMATION PROVIDED DESCRIBES PERSISTENT INFLAMMATION. NO DIAGNOSTIC TESTS WERE PERFORMED. PATIENT MANAGEMENT INCLUDED "WASHING", STEROID AND ANTIBIOTIC TREATMENT. THE PATIENT REMAINS UNDER OBSERVATION WITH THE ISSUE UNRESOLVED. IN THE REPORTER'S OPINION THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 19515588 ↗
• InjuryMay 14, 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 - 5.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS EXCHANGE RESOLVED THE PROBLEM. CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315744 ↗
• InjuryMar 29, 2024Adverse 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, -05.00 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2024 DUE TO PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH BUT DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004870 ↗
• InjuryDec 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 -5.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. IN A SEPARATE SURGERY THAT DAY THE LENS WAS EXCHANGED FOR A LENS TWO SIZES SHORTER IN LENGTH DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314576 ↗
• InjurySep 6, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2, -5.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT HAS REFRACTIVE SURPRISE. THE SURGEON PERFORMED LRI SURGERY. LENS REMAINS IMPLANTED. IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS REPORTED AS A USER ERROR WITH NO DEVICE CAUSALITY AND NOTED "SURGEON PLANNED ASTIGMATISM CORRECTION WITH LRI WHICH DOESN'T WORK". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Blurred Vision

  MAUDE report 17694988 ↗
• MalfunctionJul 11, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM ICL IMPLANTABLE COLLAMER LENS, INTO THE PATIENTS RIGHT EYE (OD). THE LENS WAS REPORTED AS HIGH VAULTING AND REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302721 ↗
• InjuryMay 3, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -5.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2023, THE LENS WAS REMOVED AND REPLACED FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865712 ↗
• InjuryApr 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; -5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. ON (B)(6) 2022 THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827520 ↗
• InjuryNov 29, 2022Inadequacy 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; -5.0 DIOPTER IMPLANTABLE COLLAMER LENS IN (B)(6) TO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. ON (B)(6) 2022, THE LENS WAS EXPLANTED. ON THIS SAME DATE A REPLACEMENT LENS OF SHORTER LENGTH WAS IMPLANTED AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883022 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.