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EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5) (REF VICM5 13.2)Recalls & reported problems

Staar Surgical Company · VICM5 - Diopter: -8.5; Overall Diameter (Length): 13.2 · Class 3 · Implant

All models of EVO/EVO+VISIAN Implantable Collamer Lens (1030)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This STAAR SURGICAL implantable collamer lens (ICL) is a corrective eye lens surgically placed in the eye. The 30 reports mostly describe the lens sitting too high or too low in the eye, causing angle closure, raised eye pressure, glare, halos, blurred vision, cataract, or a need for a second procedure to swap in a different size lens. There were no deaths, 20 injuries and 10 malfunctions, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
30
Deaths reported
0
Injuries reported
20
Recalls naming it
0

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00840311300907), received between Oct 31, 2022 and May 18, 2026 — classified as 20 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (8 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 2 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 2 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 2 reportsSep 2024: 1 reportsOct 2024: 3 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem17
  • Inadequacy of Device Shape and/or Size8
  • No Apparent Adverse Event7

Patient problems

  • No Clinical Signs, Symptoms or Conditions18
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
  • Blurred Vision3
  • Intraocular Pressure Increased2
  • Visual Disturbances2
  • Cataract1
  • Halo1

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 18, 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 WITH SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, ELEVATED IOP WITH ANGLE CLOSURE. LENS WAS REMOVED AND PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR. 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25204451 ↗
  • InjuryApr 14, 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. THE LENS WAS LATER EXCHANGED. CAUSE OF THE EVENT WAS A PATIENT-RELATED FACTOR. 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 24879336 ↗
  • InjuryFeb 8, 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. MEDICATION WAS PRESCRIBED. THE LENS REMAINS IMPLANTED. REPORTEDLY, 'DAY AFTER THE SURGERY EVERYTHING WAS FINE' AND 'WE DO NOT PLAN EXPLANTATION OF THE LENS. IT WAS ONLY TEMPORARY ELEVATION OF THE IOP.' THE CAUSE OF THE EVENT WAS REPORTED AS OTHER- 'PROBABLY OVD'.

    Patient problems: Intraocular Pressure Increased

    MAUDE report 24288304 ↗
  • InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

    A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED AN EXCESSIVE VAULT WITH GLARES/HALOES SIG REDUCTION OF ICA & SIG REDUCTION OF ICA. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS & THE PROBLEM WAS 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.

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

    MAUDE report 24195778 ↗
  • InjuryAug 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 LOW VAULT WITH CATARACT FORMATION, GLARE/HALOES, BLURRED VISION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR ALCON EPUFI IOL. PHACO-EMULSIFICATION (CATARACT SURGERY) WAS PERFORMED. THE PROBLEM WAS RESOLVED.

    Patient problems: Blurred Vision; Cataract; Halo; Visual Disturbances

    MAUDE report 22890109 ↗
  • InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PB A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. DUE TO REFRACTIVE SURPRISE, THE LENS WAS EXCHANGED FOR A SAME MODEL AND LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: Blurred Vision

    MAUDE report 22294223 ↗
  • InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HEALTH CARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. INTRAOPERATIVELY, THE SURGEON REMOVED AND REPLACED THE LENS WITH A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED.

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

    MAUDE report 21152563 ↗
  • InjuryNov 26, 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 AND REFRACTIVE SURPRISE. DUE TO EXCESSIVE VAULT AND REFRACTIVE SURPRISE, THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THIS RESOLVED THE PROBLEM. 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. 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 20777928 ↗
  • InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTITIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS FLIPPED. DUE TO THE LENS FLIPPING, THE LENS WAS REMOVED AND A REPLACEMENT LENS WAS IMPLANTED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. PER THE REPORTER "PATIENT IS DOING WELL". 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 20497250 ↗
  • InjuryOct 10, 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 HEALTH CARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED A HIGH VAULT AND NARROWED ANGLE. TO THE BEST OF OUR KNOWLEDGE, LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

    MAUDE report 20424446 ↗
  • InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HEALTHCARE PROFESSIONAL REPORTED DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY WITH A SAME LENGTH LENS. THE SAME DAY SURGICAL PI WAS PERFORMED. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS "USER ERROR" AND THE LENS DID NOT FAIL TO PERFORM AS INTENDED.

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

    MAUDE report 20370757 ↗
  • InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS "WRONG ICL SIZING."

    Patient problems: Intraocular Pressure Increased

    MAUDE report 20314101 ↗
  • 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 AN EXCESSIVE VAULT AND SHALLOW ANTERIOR CHAMBER. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. ON THE SAME DAY, SEPARATE SURGERY A REPLACEMENT LENS OF A SHORTER LENGTH WAS IMPLANTED AND THE PROBLEM WAS 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

    MAUDE report 20032717 ↗
  • 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 LOW VAULT. DUE TO LOW VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY WITH A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20031887 ↗
  • InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED LOW VAULT WITHOUT ROTATION. THE LENS WAS REMOVED AND REPLACED IN A SEPERATE SURGERY FOR A SAME MODEL BUT LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19785168 ↗
  • MalfunctionJun 23, 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 -8.50 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024 AS A REPLACEMENT LENS. THE PATIENT EXPERIENCED A LOW VAULT. THE LENS REMAINS IMPLANTED. REPORTEDLY "THE LENS REMAINS IN THE EYE AND IT WILL BE EXCHANGE FOR A 13.7 SIZE".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19591749 ↗
  • MalfunctionMay 22, 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 -8.50D IMPLANTABLE COLLAMER LENS TORE BEFORE LOADING ON (B)(6) 2024. LENS WAS STUCK IN CARTRIDGE. STATUS OF EYE IS SAME AS BEFORE SURGERY. CAUSE OF EVENT WAS REPORTED AS DEVICE; DEVICE DID FAIL TO PERFORM AS INTENDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19373168 ↗
  • InjuryMay 20, 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 -8.50 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 AN EXCESSIVE VAULT. THE EXCHANGE RESOLVED THE PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19353804 ↗
  • MalfunctionApr 21, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED A GREYISH WHITE POWDER MATERIAL WAS FOUND ON THE OUTSIDE OF THE LENS VIAL AND IN THE STERILE STORAGE PACKAGE OF A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS. THE LENS WAS A -08.50 DIOPTER, AND WAS IMPLANTED IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024 AND REMAINED IMPLANTED. THE EYE WAS QUIET.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19150061 ↗
  • MalfunctionFeb 28, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THE SURGEON REPORTED A "SCAR" ON THE OPTICAL BODY OF A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER. THERE WAS NO PATIENT CONTACT. THE "SCAR" WAS NOTED AFTER REMOVING THE LENS FROM THE VIAL. THE CAUSE OF THE EVENT WAS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18804188 ↗
  • MalfunctionFeb 2, 2024Inadequacy 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 -8.50 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. WITHIN THE INITIAL SURGERY THE LENS WAS REMOVED AND REPLACED INTRA-OPERATIVELY FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18635736 ↗
  • MalfunctionJan 5, 2024Inadequacy 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 -8.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023 AND THE PATIENT EXPERIENCED LOW VAULT. IT WAS REPORTED THAT MEDICAL OR SURGICAL INTERVENTION IS NOT NECESSARY. REPORTER STATED THAT THE PATIENT IS HAPPY AND THE DOCTOR WILL MONITOR PATIENT CLOSELY. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18460083 ↗
  • MalfunctionNov 7, 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 THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) -2023. THE LENS WAS REMOVED DUE TO ZERO VAULT. THIS WAS THE REPLACEMENT LENS FOR MFR. REPORT # 2023826-2023-04759. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18088972 ↗
  • InjuryOct 20, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

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

    MAUDE report 17978644 ↗
  • InjuryOct 13, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO EXCESSIVE VAULTING AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

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

    MAUDE report 17932866 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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.
  • 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-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.

Other Lens, Intraocular, Phakic devices

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Sources and updates

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