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EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-7.0) (REF VICM5 13.2)Recalls & reported problems

Staar Surgical Company · VICM5 - Diopter: -7.0; 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 (VICM5 13.2, -7.0 diopter) is an implantable lens surgically placed in the eye to correct vision. The 27 reports mostly describe vision staying blurry or over- and under-corrected after surgery, inflammation such as toxic anterior segment syndrome or uveitis, and lenses sitting too close to the cornea, sometimes requiring an exchange with a shorter lens. Some reports mention the lens being implanted upside down. There are 23 injuries and no deaths, 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
28
Deaths reported
0
Injuries reported
24
Recalls naming it
0

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00840311300877), received between Apr 4, 2023 and Sep 30, 2026 — classified as 24 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 4 reportsMay 2024: 3 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 3 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 3 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem21
  • No Apparent Adverse Event4
  • Misfocusing2
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • No Clinical Signs, Symptoms or Conditions13
  • Blurred Vision6
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
  • Toxic Anterior Segment Syndrome (TASS)2
  • Inflammation1
  • Uveitis1
  • Visual Disturbances1

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

    Patient problems: Visual Disturbances

    MAUDE report 50953106 ↗
  • 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. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Inflammation

    MAUDE report 25379536 ↗
  • InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS WAS IMPLANTED UPSIDE DOWN. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SAME MODEL, SIZE AND POWER REPLACEMENT LENS. THE REPLACEMENT LENS RESOLVED THE PROBLEM.

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

    MAUDE report 24973661 ↗
  • InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS WAS IMPLANTED UPSIDE DOWN. THERE WAS PATIENT CONTACT AND NO PATIENT INJURY. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A LENS OF THE SAME PARAMETERS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. IT HAS BEEN NOTED THAT THE SURGEON SELECTED A DIFFERENT LENS SIZE THAN THAT INITIALLY SUGGESTED BY THE ICL CALCULATION SOFTWARE.

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

    MAUDE report 24300478 ↗
  • InjuryNov 4, 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 OVER/UNDER CORRECTION. THE LENS EXCHANGED FOR A SAME LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS USE ERROR," SURGEON USED THE WRONG PRAOP DATAS FOR CALCULATION. NEW CALCULATION WAS MADE, AND A NEW LENS WAS ORDERED. PATIENT IS HAPPY."

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

    MAUDE report 23468338 ↗
  • InjuryNov 3, 2025Adverse 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 SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, SHALLOW AC. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 23459463 ↗
  • InjuryNov 3, 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 EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, AND SIGNIFICANT REDUCTION OF ENDOTHELIAL CELL COUNT. THE LENS REMAINS IMPLANTED. CAUSE OF THE EVENT IS 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: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23447349 ↗
  • InjuryOct 28, 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 EXCESSIVE VAULT AND BLURRED VISION. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS, AND THE PROBLEM WAS RESOLVED. THE CAUSE OF EVENT WAS UNKNOWN," PATIENT COMPLAINING OF BLURRED VISION VAULT IS 175% AND WAITING FOR FOLLOW UP WITH SURGEON." 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: Blurred Vision

    MAUDE report 23405674 ↗
  • InjuryOct 28, 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 EXCESSIVE VAULT AND BLURRED VISION. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS, AND THE PROBLEM WAS RESOLVED. THE CAUSE OF EVENT WAS UNKNOWN," PATIENT COMPLAINING OF BLURRED VISION VAULT IS 120% AND WAITING FOR SURGEON FOLLOW UP." 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 23405673 ↗
  • InjuryMar 14, 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 UVEITIS/IRITIS. DIAGNOSTIC CULTURES WERE NOT PERFORMED. THE PATIENT WAS TREATED WITH "STEROID EYE DROPS, ANTERIOR CHAMBER RINSING" IN A SEPARATE VISIT THE LENS WAS EXPLANTED, AND THE PROBLEM WAS RESOLVED.

    Patient problems: Uveitis

    MAUDE report 21612426 ↗
  • InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A HEALTHCARE PROFESSIONAL REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO A PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. THE LENS WAS EXCHANGED WITH A SHORTER LENGTH LENS AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21024440 ↗
  • InjuryDec 4, 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. DUE TO EXCESSIVE VAULT, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR A SHORTER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20847264 ↗
  • InjuryDec 2, 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 A REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SAME SIZE LENS BUT DIFFERENT DIOPTER. THE PROBLEM WAS RESOLVED. CAUSE REPORTED AS A PATIENT RELATED FACTOR. 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 20826915 ↗
  • InjuryAug 9, 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 A LOW VAULT. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. ON THE SAME DAY SEPARATE SURGERY THE LENS WAS REPLACED WITH A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19951697 ↗
  • MalfunctionJul 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

    A FACILITY REPRESENTATIVE REPORTED THAT PRIOR TO AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS TORE DURING LOADING. THE LENS WAS NOT IMPLANTED. CAUSE OF EVENT WAS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19733587 ↗
  • InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -7.0 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED WITH A SAME MODEL BUT SHORTER LENGTH LENS ON DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN AND UNKNOWN IF DEVICE FAILED TO PERFORM AS INTENDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19567843 ↗
  • InjuryMay 21, 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, -07.00 DIOPTER, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS EXPLANTED ON (B)(6) 2024 DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19367352 ↗
  • InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -7.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED ON (B)(6) 2024. IT WAS INDICATED THAT THE AC IS STABLE AND THE SURGEON PLANS ICL REPLACEMENT AFTER REPEAT REFRACTION. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: Blurred Vision

    MAUDE report 19256155 ↗
  • MalfunctionMay 3, 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, -07.00 DIOPTER, DURING THE SAME SURGERY DUE TO THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENTS LEFT EYE (OS). THERE WAS NO PATIENT 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 19242247 ↗
  • InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE SURGEON IMPLANTED A VICM5 13.2 -07.00D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE OPEGAN AND THE MSI INJECTOR DELIVERY SYSTEM. TOXIC ANTERIOR SEGMENT SYNDROME ( TASS) WAS OBSERVED AND PER REPORTER, UNKNOWN DIAGNOSTICS AND TREATMENT WERE PERFORMED. ON (B)(6) 2024 (DAY 8) THE LENS WAS EXCHANGED. ANTERIOR CHAMBER IRRIGATION AND EVACUATION OF VISCO/FLUIDS WAS PERFORMED. THE LENS WAS EXCHANGED WITH ANOTHER ICL OF THE SAME MODEL, LENGTH, AND POWER. PROBLEMS RESOLVED. THE LAST REPORT WAS RECEIVED ON 02-APR-2024. 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 19195772 ↗
  • InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5 -7.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL ICL SURGERY. THE MSI INJECTOR DELIVERY SYSTEM WAS USED BUT THE VISCOELASTIC TYPE USED DURING PROCEDURE WAS NOT PROVIDED. TASS WAS DIAGNOSED. DIAGNOSTICS WERE PERFORMED AND DEPOSITS IDENTIFIED ON THE BACK OF THE LENS. IT WAS ALSO REPORTED THAT ONSET OF PROBLEM WAS 1 MONTH AFTER SURGERY AND THAT ADDITIONAL PROCEDURES WERE PERFORMED: "EAR SIDE INCISION. VERTICAL FIXATION. PER LAST REPORT, DATED ON (B)(6) 2024, THE PATIENT HAD NO SUBJECTIVE SYMPTOMS AND REMAINS UNDER OBSERVATIONS. THE LENS REMAINS IMPLANTED. IN THE REPORTER'S OPINION CAUSE OF THE EVENT IS UNKNOWN.

    Patient problems: Toxic Anterior Segment Syndrome (TASS)

    MAUDE report 19130461 ↗
  • InjuryApr 18, 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; -7.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS REPORTED AS HAVING EXCESSIVE VAULT. CAUSE OF THE EVENT WAS NOT REPORTED. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS. THIS RESOLVED THE PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19130375 ↗
  • InjuryApr 18, 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; -7.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2024. THE LENS WAS REPORTED AS HAVING EXCESSIVE VAULT. CAUSE OF THE EVENT WAS NOT REPORTED. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS. THIS RESOLVED THE PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19130288 ↗
  • InjuryJan 20, 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 -7.0 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 18548589 ↗
  • InjuryDec 4, 2023Misfocusing; Misfocusing

    THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -7.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS REPLACED WITH A SAME SIZE , DIFFERENT DIOPTER (SPHERE/CYLINDER/AXIS) LENS DUE TO REFRACTIVE SURPRISE(ASSESSED ON (B)(6) 2023). THE PROBLEM WAS RESOLVED.

    Patient problems: Blurred Vision

    MAUDE report 18258205 ↗

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-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-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-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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