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EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.5) (REF VICM5 12.6)Recalls & reported problems

Staar Surgical Company · VICM5 - Diopter: -9.5; Overall Diameter (Length): 12.6 · 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 prescription eye lens implanted to correct vision. Reports mostly describe the lens fitting poorly after surgery — too shallow or too deep a fit, rotation, or a power that left patients over- or under-corrected — and in many cases the lens had to be removed and swapped. Patients also mentioned blurred vision, eye discomfort, higher eye pressure, inflammation, and cataract. There are 34 reports, 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
34
Deaths reported
0
Injuries reported
25
Recalls naming it
0

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00840311300594), received between Mar 1, 2023 and Jun 24, 2026 — classified as 25 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (9 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: 1 reportsFeb 2024: 2 reportsMar 2024: 3 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 4 reportsDec 2024: 2 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 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 Problem17
  • Inadequacy of Device Shape and/or Size9
  • No Apparent Adverse Event7
  • Off-Label Use2
  • Device Dislodged or Dislocated1
  • Optical Problem1
  • Product Quality Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions20
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
  • Blurred Vision2
  • Cataract2
  • Intraocular Pressure Increased2
  • Toxic Anterior Segment Syndrome (TASS)2
  • Discomfort1
  • Halo1

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED OVER/UNDER CORRECTION. THE LENS WAS EXCHANGED FOR A SAME MODEL, POWER AND LENGTH LENS. THE PROBLEM WAS RESOLVED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 25610551 ↗
  • InjuryMay 7, 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 FOR A SAME SIZE, TORIC LENS. THE PROBLEM WAS RESOLVED.

    Patient problems: Blurred Vision

    MAUDE report 25112174 ↗
  • InjuryFeb 12, 2026Adverse 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. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR THE SAME SIZE BUT DIFFERENT POWER. THE REPLACEMENT LENS RESOLVED THE PROBLEM.

    Patient problems: Blurred Vision

    MAUDE report 24326749 ↗
  • InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE AS A REPLACEMENT LENS. THE SURGEON NOTED LASEK WAS PERFORMED FOR ASTIGMATISM. PROBLEM WAS RESOLVED.

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

    MAUDE report 24242001 ↗
  • InjuryDec 2, 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 DISCOMFORT, "CLOSE UP VIEW IS TIRING." IN A SEPARATE VISIT THE LENS WAS EXPLANTED. 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: Discomfort

    MAUDE report 23694142 ↗
  • InjuryJun 24, 2025Adverse 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 WITH ROTATION. DUE TO LOW VAULT WITH ROTATIOM, THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS. THE PROBLEM WAS RESOLVED. CAUSE IS UNKNOWN. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF [INSERT TOTAL # OF REPORTS] 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 22318504 ↗
  • InjuryMar 31, 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 RESIDUAL ASTIGMATISM. PATIENT WAS TREATED WITH LASIK. 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. CAUSE OF EVENT WAS NOT REPORTED.

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

    MAUDE report 21732300 ↗
  • InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAER LENS (ICL) IMPLANTATION PROCEDURE THE PATIENT EXPERIENCED EXCESSIVE VAULT WITH SIGNIFICANT REDUCTION IN IRIDIOCORNEAL ANGLES WITH ELEVATED IOP. THE CAUSE OF THE EVENT WAS REPORTED TO BE PATIENT RELATED FACTOR. THE COMPLAINT STATED THAT "PATIENT EXTREMELY REACTIVE WITH SCHIZOPHRENIA, EXPLANTATION DECISION". THE LENS WAS REMOVED. PER THE MEDICAL REVIEW THIS CLAIM IS DEEMED SERIOUS WITH UNKNOWN DEVICE CAUSALITY.

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

    MAUDE report 21551708 ↗
  • MalfunctionDec 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT. THE LENS REMAINS IMPLANTED. 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 20845126 ↗
  • InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO A RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE THE ACCUJECT UNIFIT INJECTOR, SFC-45 CARTRIDGE WITH FOAM TIP PLUNGER, OVD (OPEGAN, OPEGAN HI) AND COAXIAL I/A HANDPIECE FOR ITS REMOVAL FOR 60 SEC. TASS WAS DIAGNOSED ON DAY 1. INFLAMMATION WAS REPORTED AS MODERATE PRESENTING WITH AC CELL+++, CONJUNCTIVAL HYPEREMIA AND MODERATE FIBRIN OVER THE PUPIL RESULTING IN PATIENT EXPERIENCE OF BLURRED VISION. TREATMENT INCLUDED: AC LAVAGE, TOPICAL, ORAL AND SUBCONJUNCTIVAL INJECTION OF STEROIDS. THE ISSUE WAS RESOLVED ON DAY 2 AND THE LENS REMAINS IMPLANTED. PER INFORMATION ON (B)(6) 2024, OCULAR STATUS WAS REPORTED AS BCVA 20/13 AND IOP 11MMHG. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT.

    Patient problems: Toxic Anterior Segment Syndrome (TASS)

    MAUDE report 20843568 ↗
  • MalfunctionNov 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

    A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE DELIVERY SYSTEM EXPERIENCED ISSUES. THE LENS TORE DURING LOADING. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY. A REPLACEMENT LENS WAS LATER IMPLANTED. PROBLEM RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20723568 ↗
  • InjuryNov 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 A REFRACTIVE SURPRISE. DUE TO THE REFRACTIVE SURPRISE, THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY FOR ANOTHER SAME MODEL/LENGTH BUT DIFFERENT POWER LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. THERE ARE MULTIPLE 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 20677399 ↗
  • InjuryNov 12, 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 LENS OPACITY. THE LENS WAS EXCHANGED WITH A LONGER LENGTH LENS AND THIS RESOLVED THE PROBLEM. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: Cataract

    MAUDE report 20670009 ↗
  • MalfunctionNov 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. LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED AND REPLACED WITH A SHORTER LENGTH LENS AND PROBLEM WAS RESOLVED. CAUSE OF EVENT WAS NOT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20601711 ↗
  • MalfunctionOct 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED ISSUES. THE LENS WAS IMPLANTED UPSIDE DOWN IN THE EYE AND THE LENS WAS REMOVED. THE LENS WAS EXCHANGED WITH THE BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20474446 ↗
  • InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT AFTER IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION INTO THE PATIENT'S EYE, TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. NO ADDITIONAL DIAGNOSTICS WERE PERFORMED. SEVERITY WAS NOT PROVIDED. INFORMATION REGARDING CONCOMITANT PRODUCTS USED INTRAOPERATIVELY WAS NOT PROVIDED. IN A SEPARATE VISIT TREATMENT WAS PERFORMED OF CLEANING AND LENS REMOVAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Toxic Anterior Segment Syndrome (TASS)

    MAUDE report 20215007 ↗
  • InjuryAug 12, 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 WAS DISSATISFIED. THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY WITH A TORIC LENS DUE TO ASTIGMATISM AND PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS NOT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19962122 ↗
  • InjuryJun 27, 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 VICM5 12.6 IMPLANTABLE COLLAMER LENS -9.5 DIOPTER INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023 AFTER IT WAS STUCK IN THE CARTRIDGE/INJECTOR AND WAS DAMAGED ON DELIVERY. THE LENS WAS REPORTED AS HAVING LOW VAULTING WITHOUT ROTATION. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A LONGER LENGTH LENS. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS THE DEVICE. THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19628953 ↗
  • MalfunctionMay 24, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF -9.50 DIOPTER WAS IMPLANTED UPSIDE DOWN INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FOR A SAME SIZE LENS. THE DEVICE WAS REPORTED AS THE CAUSE OF THE EVENT. THE PROBLEM WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19397799 ↗
  • InjuryApr 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -9.5 DIOPTER TORE DURING LOADING ON (B)(6) 2024. THERE WAS NO PATIENT CONTACT. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS ON (B)(6) 2024. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19140413 ↗
  • MalfunctionMar 26, 2024Product Quality Problem; Product Quality Problem

    THE REPORTER INDICATED THAT A VIAL WITH A 12.6MM, VICM5_12.6, -9.5 DIOPTER, IMPLANTABLE COLLAMER LENS HAD WHITEISH POWDER ON THE VIAL AND THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18979480 ↗
  • InjuryMar 25, 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 VICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.50 DIOPTER, INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO PATIENT EXPERIENCED A REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH BUT DIFFERENT DIOPTER LENS AND THE PROBLEM WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18975702 ↗
  • MalfunctionMar 5, 2024No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_ 12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -9.5 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT EXPERIENCED LOW VAULTING. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED 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 18842607 ↗
  • InjuryFeb 12, 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 VICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.50 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2024 DUE TO A LENS OPACITY (CORTICAL CATARACT) WAS OBSERVED. PHACO-EMULSIFICATION (CATARACT SURGERY) WAS PERFORMED AND AN IOL WAS IMPLANTED. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.

    Patient problems: Cataract

    MAUDE report 18691869 ↗
  • InjuryFeb 2, 2024Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Optical Problem; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Optical Problem

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO LOW VAULTING, ELEVATED INTRAOCULAR PRESSURE (IOP), LENS DISLOCATION/SUBLUXATION AND GLARE/HALOS. THE LENS WAS REPOSITIONED ON (B)(6) 2023 BUT THE PROBLEM WAS NOT RESOLVED AND THE LENS WAS REMOVED. THE LENS WAS REPLACED WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS THE DEVICE.

    Patient problems: Halo; Intraocular Pressure Increased; Visual Disturbances

    MAUDE report 18632502 ↗

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-0474-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
  • Z-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-0466-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

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Sources and updates

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