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EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-10.0) (REF VICM5 13.2)Recalls & reported problems

Staar Surgical Company · VICM5 - Diopter: -10.0; 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 (ICL) is a phakic intraocular lens surgically implanted in the eye to correct vision. The 29 reports mostly describe the lens sitting too far forward (excessive vault), raising eye pressure and narrowing drainage angles, along with blurred vision, glare, halos, and sometimes a need to swap in a shorter lens. Reports mention 25 injuries and no deaths. 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 00840311300938), received between Nov 2, 2022 and Jun 11, 2026 — classified as 24 injuries, 4 malfunctions.

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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 4 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 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 Problem20
  • No Apparent Adverse Event6
  • Inadequacy of Device Shape and/or Size2
  • Misfocusing2
  • Improper or Incorrect Procedure or Method1
  • Off-Label Use1
  • Unintended Movement1

Patient problems

  • No Clinical Signs, Symptoms or Conditions11
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
  • Intraocular Pressure Increased6
  • Blurred Vision4
  • Cataract2
  • Toxic Anterior Segment Syndrome (TASS)1
  • Visual Disturbances1

Recent adverse event reports

The 25 most recent of 28 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 25479462 ↗
  • InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED 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, LENGTH BUT DIFFERENT POWER LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: Blurred Vision

    MAUDE report 24750896 ↗
  • InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE AND CORNEAL SWELLING. DUE TO REFRACTIVE SURPRISE AND CORNEAL SWELLING, THE LENS WAS EXPLANTED. ON THE SAME DAY IN A SEPARATE SURGERY THE LENS WAS REPLACED FOR A SAME MODEL, LENGTH BUT WEAKER POWER LENS. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: Blurred Vision

    MAUDE report 24612086 ↗
  • InjuryFeb 5, 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 EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF ICA, SHALLOWING OF AC. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE REPLACEMENT LENS RESOLVED THE PROBLEM. 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 24272667 ↗
  • InjuryDec 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 AN EXCESSIVE VAULT. ELEVATED IOP, SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES AND SHALLOWING OF THE AC. TREATMENT FOR ELEVATED IOP WAS ADMINISTERED. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS. THE REPLACEMENT LENS RESOLVED THE PROBLEM. CAUSE REPORTED AS OTHER.

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

    MAUDE report 23915609 ↗
  • InjuryDec 22, 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 GLARE/HALOES. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS. THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: Visual Disturbances

    MAUDE report 23873749 ↗
  • InjurySep 19, 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 AN EXCESSIVE VAULT WITH SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES, AND SIGNIFICANT SHALLOWING OF THE AC. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND 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

    MAUDE report 23097310 ↗
  • InjuryAug 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 A REFRACTIVE CHANGE OVER TIME AND TRANSIENT LOSS OF BCVA. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Blurred Vision

    MAUDE report 22705320 ↗
  • InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS TORE /BROKE DURING INJECTION/DELIVERY INTO THE EYE. ON A SEPARATE DAY DUE TO THE LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE EYE, THE LENS WAS EXPLANTED. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.

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

    MAUDE report 22576999 ↗
  • InjuryFeb 6, 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 AND CATARACT. THE LENS REMAINS IMPLANTED. 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. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Cataract

    MAUDE report 21327715 ↗
  • InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IL A FACILITY REPRESENTATIVE REPORTED THAT DURING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS WAS IMPLANTED UPSIDE DOWN. IN A SEPARATE VISIT THE LENS WAS REMOVED AND WAS REIMPLANTED IN THE CORRECT POSITION AND THE PROBLEM RESOLVED. CAUSE OF EVENT WAS 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 THAT 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 20872731 ↗
  • InjurySep 18, 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 HIGH VAULT AND INTRAOCULAR PRESSURE RISE. LENS REMAINS IMPLANTED. PER HEALTHCARE PROFESSIONAL VA EXCEEDS PRE-OP BCVA AND PATIENT IS HAPPY. 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 THAT 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 20251929 ↗
  • InjurySep 17, 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, ELEVATED IOP AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS OF SHORTER LENGTH 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 THAT 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; Intraocular Pressure Increased

    MAUDE report 20242400 ↗
  • InjurySep 17, 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, ELEVATED IOP AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A REPLACEMENT LENS OF SHORTER LENGTH AND THE PROBLEM 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 THAT 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; Intraocular Pressure Increased

    MAUDE report 20242349 ↗
  • InjurySep 16, 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 AND REFRACTIVE SURPRISE. THE LENS WAS REMOVED BUT PROBLEM WAS NOT RESOLVED. STATUS OF EYE "QUIET EYE AWAITING IMPLANTATION OF THE CORRECT LENS." CAUSE OF THE EVENT WAS REPORTED AS DEVICE - "DURING IMPLANTATION, ONCE THE LENS WAS INSERTED, THE SURGEON NOTICED THE 'TORIC ALIGHMENT MARKS' DESPITE BEING SPHERICAL".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20227217 ↗
  • 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 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; No Clinical Signs, Symptoms or Conditions

    MAUDE report 20037781 ↗
  • InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. LOW VAULT WAS OBSERVED. SURGEON PLANS TO REMOVE AND REPLACE THE LENS. LENS REMAINS IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Cataract; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19316152 ↗
  • InjuryMar 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_13.2; -10 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED LOW VAULTING. ON (B)(6) 2024 THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18927328 ↗
  • InjuryMar 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_13.2; -10.0 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023 AS A REPLACEMENT LENS. THE PATIENT EXPERIENCED LOW VAULTING. ON (B)(6) 2024 THE LENS WAS EXPLANTED, AND ON THIS SAME DATE A REPLACEMENT LENS OF LONGER LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18927327 ↗
  • InjuryFeb 14, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM, VICM5 13.2, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). ELEVATED IOP WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: Intraocular Pressure Increased

    MAUDE report 18704969 ↗
  • InjuryDec 12, 2023Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; 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 -10.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A LONGER LENGTH LENS DUE TO LOW VAULT AND THIS RESOLVED THE PROBLEM. CAUSE OF EVENT REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18311784 ↗
  • InjuryNov 22, 2023Misfocusing; Misfocusing

    THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -10.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON 18- SEP-2023. REFRACTIVE SURPRISE WAS REPORTED, LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Blurred Vision

    MAUDE report 18196960 ↗
  • InjuryMay 31, 2023Misfocusing; Misfocusing

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -10.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. BLURRED VISION AND TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS OBSERVED. DIAGNOSTICS WERE PERFORMED. AN ADDITION OF ORAL STEROIDS AND OINTMENTS WERE PRESCRIBED. CAUSE OF THE EVENT IS UNKNOWN.

    Patient problems: Toxic Anterior Segment Syndrome (TASS)

    MAUDE report 17035359 ↗
  • MalfunctionMay 30, 2023No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT ON (B)(6) 2023 A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -10.00 DIOPTER TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY WITH NO PATIENT INJURY. CAUSE OF EVENT WAS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17025233 ↗
  • MalfunctionMar 2, 2023Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -10.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED DUE TO THE INITIAL LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16471711 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. 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-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.

Other Lens, Intraocular, Phakic devices

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Sources and updates

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