EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-4.5) (REF VICM5 12.6)Recalls & reported problems
Staar Surgical Company · VICM5 - Diopter: -4.5; 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 EVO implantable lens is placed in the eye to correct nearsightedness. Reports mostly describe vision problems such as blur, glare and halos or over- and under-correction, sometimes with fit or insertion problems leading to the lens being exchanged or removed, plus increased eye pressure and inflammation. There are 25 reports that name its identifier, with no deaths and 17 injuries, 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
- 25
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00840311300495), received between May 17, 2023 and Apr 17, 2026 — classified as 17 injuries, 8 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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- No Apparent Adverse Event7
- Inadequacy of Device Shape and/or Size2
- Misfocusing2
- Off-Label Use1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Visual Disturbances4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Blurred Vision3
- Intraocular Pressure Increased3
- Swelling/ Edema2
- Toxic Anterior Segment Syndrome (TASS)2
- Halo1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 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 LENGTH, DIFFERENT POWER LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN.
Patient problems: Visual Disturbances
MAUDE report 24913066 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCES WITH NEAR VISION. THE LENS WAS EXPLANTED, AND THE PROBLEM WAS RESOLVED.
Patient problems: Visual Disturbances
MAUDE report 24416240 ↗InjuryDec 18, 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 GLARES/HALOES. THE LENS WAS EXPLANTED AND PROBLEM RESOLVED. ADDITIONAL NOTES INDICATED, "PT. BOTHERED BY GLARE POST EVO, REQUESTED LENS BE REMOVED." 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: Visual Disturbances
MAUDE report 23845127 ↗InjuryNov 20, 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 SURGEON NOTES THERE WAS A PROBLEM WITH INSERTION, LENS GOT STUCK AND COULD NOT GET UNFURLED. THE LENS WAS IMPLANTED UPSIDE DOWN. IT WAS NOTED THERE WAS PATIENT INJURY, MILD ENDOTHELIAL DAMAGE AND GLARE/HALOES WITH SMALL RING IN VISION. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH A SAME LENGTH AND POWER LENS. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE AND USE ERROR.
Patient problems: Halo
MAUDE report 23612483 ↗InjuryJun 20, 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 UNDER REFRACTION. THE LENS WAS LATER EXCHANGED FOR A SAME SIZE, SAME MODEL, DIFFERENT POWER 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: Visual Disturbances
MAUDE report 22303165 ↗InjuryDec 2, 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 LEFT EYE (OS) ON (B)(6) 2024. THE OS WAS THE SECOND EYE OF BILATERAL SEQUENTIAL SURGERY. CONCOMITANT PRODUCTS USED INTRAOPERATIVELY INCLUDE: 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 POST-OP DESCRIBED AS MILD INFLAMMATION WITH CELL++, CONJUNCTIVAL HYPEREMIA, MODERATE DEPOSITION (UNSPECIFIED) ON THE LENS SURFACE AND PATIENT EXPERIENCE OF BLURRED VISION. FREQUENT STEROID DROPS AND ORAL STEROIDS WERE PRESCRIBED. ON DAY 2 THE ISSUE WAS REPORTED AS RESOLVED WITH BCVA 20/17 AND IOP 10MMHG. THE LENS REMAINS IMPLANTED. THE REPORTER DOES NOT STATE A CAUSE FOR THE EVENT.
Patient problems: Blurred Vision; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 20825770 ↗MalfunctionNov 14, 2024No Apparent Adverse Event; No Apparent Adverse Event
A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED LOW VAULTING. THE LENS WAS INTRAOPERATIVELY REMOVED. IT WAS NOTED NEXT OPERATION DATE IS NOT YET DECIDED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20688052 ↗MalfunctionNov 10, 2024No Apparent Adverse Event; No Apparent Adverse Event
A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. TO THE BEST OF OUR KNOWLEDGE THE LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20648605 ↗InjuryNov 6, 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 REFRACTIVE SURPRISE. DUE TO REFRACTIVE SURPRISE THE LENS WAS EXCHANGED WITH A SAME SIZE BUT DIFFERENT MODEL LENS. CAUSE OF THE EVENT WAS REPORTED AS OTHER.
Patient problems: Blurred Vision
MAUDE report 20624698 ↗InjuryOct 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 BLURRED VISION AND HAS DIFFICULTY ADAPTING TO MONOVISION. DUE TO BLURRED VISION AND DIFFICULTY ADAPTING TO MONOVISION THE LENS WAS EXPLANTED. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20511144 ↗InjuryOct 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 EXCESSIVE VAULT. DUE TO EXCESSIVE VAULT THE LENS EXCHANGED WITH A SHORTER LENGTH LENS. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20510993 ↗InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 12.6MM, VICM5_12.6, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED UPSIDE DOWN INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. PATIENT CONTACT(LENS TOUCHED THE EYE). NO PATIENT INJURY. ON (B)(6) 2024 THE LENS WAS REPLACED WITH A SAME SIZE , SAME DIOPTER LENS DUE TO FARSIGHTEDNESS AND ASTIGMATISM DIFFICULTY. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.
Patient problems: Swelling/ Edema
MAUDE report 19167467 ↗MalfunctionApr 23, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 12.6MM, VICM5_12.6, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. EDEMA AND INFLAMMATION WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: Swelling/ Edema
MAUDE report 19167445 ↗InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5 -4.50D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT UNDERWENT BILATERAL SEQUENTIAL ICL SURGERY. TASS WAS DIAGNOSED. DIAGNOSTICS WERE PERFORMED AND DEPOSIT AND WHITE THREAD-LIKE SUBSTANCE WERE OBSERVED BEHIND THE LENS, BUT NO ADDITIONAL TREATMENT WAS PRESCRIBED. IT WAS ALSO REPORTED THAT ONSET OF PROBLEM WAS 1 MONTH AFTER SURGERY AND THAT ADDITIONAL PROCEDURES WERE PERFORMED: "UPPER SIDE INCISION. HORIZONTAL FIXATION." AS OF (B)(6) 2024 PROBLEM WAS NOT RESOLVED AND PATIENT WAS UNDER OBSERVATION. THE REPORTER STATES CAUSE OF THE EVENT WAS UNKNOWN. THE LENS REMAINS IMPLANTED.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 19105649 ↗MalfunctionFeb 20, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -04.50 DIOPTER, TORE, BROKE DURING LOADING AND THE LENS WAS NOT IMPLANTED. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL, LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18743720 ↗InjuryFeb 20, 2024Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 12.6MM, VICM512.6, -4.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. PERMANENT LOSS OF BCVA (ASSESSED ON (B)(6) 2023), ANTERIOR SUBCAPSULAR, CAPSUAR FIBROSIS AND LENS OPACITY ASC(OBSERVED ON (B)(6) 2023) WAS OBSERVED. LENS WAS EXPLANTED ON (B)(6) 2023. PHACO-EMULSTIFICATION(CATARACT SURGERY) &IOL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18738724 ↗InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 12.6MM VICM5 IMPLANTABLE COLLAMER LENS OF -4.50D WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE PATIENT UNDERWENT BILATERAL ICL IMPLANTATION ON THE SAME DAY. ELEVATED IOP WAS NOTED APPROXIMATELY 3 MONTHS POST-OP. PIGMENT DISPERSION AND INFLAMMATION ARE OBSERVED ON AN UNKNOWN DATE. AT PATIENT REQUEST LENS EXPLANT WAS PERFORMED ON (B)(6) 2023 BY A DIFFERENT SURGEON WHO CONTINUES TO MONITOR THE IOP. THE PATIENT REFUSES TO RETURN TO THE IMPLANTING SURGEON. THE REPORTER DID NOT PROVIDE LAST VISUAL ACUITY OR OCULAR STATUS AS THE PATIENT IS UNDER THE CARE OF A DIFFERENT MEDICAL PROVIDER. BASED ON CLINIC REPORTED PRE-OP WTW & ACD, THE SURGEON IMPLANTED A SHORTER LENS THAN SUGGESTED BY THE DIRECTIONS FOR USE. IN THE REPORTER'S OPINION THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Intraocular Pressure Increased
MAUDE report 18700892 ↗InjuryJan 22, 2024Misfocusing; Misfocusing
THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF -4.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). ON (B)(6) 2023 THE LENS WAS EXCHANGED FOR A DIFFERENT POWER LENS DUE TO REFRACTIVE SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: Blurred Vision
MAUDE report 18560295 ↗MalfunctionJan 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF -4.5 DIOPTER, WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FOR A SHORTER LENGTH LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023 DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18472314 ↗InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF -4.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023, ELEVATED IOP WITHOUT PUPIL BLOCK WAS OBSERVED. ON (B)(6) 2023, THE LENS WAS REMOVED. REPORTEDLY, "LEFT EYE ANTERIOR CHAMBER STILL HAS DENCE AC CELLS AND INV PIGMENTS DESPITE FREQUENT TOMZAL STERIOD." CAUSE OF THE EVENT IS UNKNOWN.
Patient problems: Intraocular Pressure Increased
MAUDE report 18437835 ↗InjuryOct 30, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -4.5 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. THIS RESOLVED THE PROBLEM. CAUSE OF EVENT REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18035694 ↗MalfunctionAug 16, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -4.5 DIOPTER TORE DURING LOADING IN THE CARTRIDGE. LENS WAS NOT IMPLANTED. ON (B)(6) 2023, THE REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS UNKNOWN. REPORTEDLY, "A FEW STRIAE ON THE ENOTHELIUM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17561601 ↗InjuryAug 16, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A REPLACEMENT 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -4.5 WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)6) 2023. THE PROBLEM WAS RESOLVED. REPORTEDLY, "A FEW STRIAE ON THE ENDOTHELIUM."
Patient problems: Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions
MAUDE report 17561598 ↗MalfunctionJul 25, 2023Unintended Movement; Unintended Movement
THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF -9.5 DIOPTER WAS IMPLANTED UPSIDE DOWN INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED DUE TO THE LENS BEING IMPLANTED UPSIDE DOWN. THERE WAS PATIENT CONTACT BUT NO INJURY. THE PROBLEM WAS RESOLVED. REPORTEDLY, "NO SIGNS/SYMPTOMS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17394081 ↗MalfunctionMay 17, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Off-Label Use; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -4.5 DIOPTER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENT'S RIGHT EYE (OD). THE LENS WAS NOT IMPLANTED. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. CAUSE OF EVENT WAS THE DEVICE. REPORTEDLY, "EYE IS IN GOOD CONDITION AND READY TO IMPLANT NEW ICL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16950898 ↗
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, ClassifiedEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0464-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0469-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Other Lens, Intraocular, Phakic devices
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall12 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.0)Staar Surgical Company · Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.5)Staar Surgical Company · Lens, Intraocular, Phakic1 recall8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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