EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0) (REF VICM5 13.2)Recalls & reported problems
Staar Surgical Company · VICM5 - Diopter: -11.0; 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 EVO implantable lens is placed in the eye to correct vision. Reports mostly describe the lens sitting too high or not fitting well, often leading to removal and replacement with a shorter lens, with some mentions of blurred vision, glare and eye infection. There are 23 reports naming its identifier, with 19 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
- 23
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00840311300952), received between Mar 17, 2023 and Feb 5, 2026 — classified as 19 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 Problem17
- Inadequacy of Device Shape and/or Size3
- No Apparent Adverse Event3
- Misfocusing1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Blurred Vision2
- Visual Disturbances2
- Endophthalmitis1
- Halo1
- Hypopyon1
- Intraocular Pressure Increased1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
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 24272624 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2025. THE PATIENT EXPERIENCED ENDOPHTHALMITIS WHICH WAS NOTED ON (B)(6) 2025. PATIENT HAD A BILATERAL SEQUENTIAL SURGERY. CULTURES WERE PERFORMED AND RESULTS ARE UNKNOWN. TREATMENT WAS ALSO PERFORMED (MEDICATION). THE LENS WAS EXPLANTED BUT IT WAS NOTED THE PROBLEM IS NOT RESOLVED.
Patient problems: Endophthalmitis; Hypopyon
MAUDE report 24060621 ↗InjuryDec 1, 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 REFRACTIVE SURPRISE. THE LENS EXPLANTED AND REPLACED WITH THE SAME SIZE DIFFERENT POWER LENS AND THE PROBLEM RESOLVED. THE CAUSE OF 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: Blurred Vision
MAUDE report 23687488 ↗InjuryNov 10, 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 ROTATION. THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. KERATITIS WAS LATER NOTED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23518636 ↗InjuryOct 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, LENS ROTATION. THE LENS WAS REPOSITIONED BUT THE PROBLEM WAS NOT RESOLVED. THE LENS WAS THEN EXPLANTED AND REPLACED WITH A SHORTER 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 23362615 ↗InjuryMay 12, 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 SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS AND 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. CAUSE OF THE EVENT WAS REPORTED AS DEVICE/PATIENT-RELATED FACTOR/USER ERROR - LENS TOO LARGE FOR EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22004905 ↗InjuryMar 7, 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 UNREACTIVE FIXED PUPIL, PIGMENT DISPERSION, GLARES/HALOES, ELEVATED IOP AND MEDICATION WAS PRESCRIBED. REPORTEDLY, "IT'S BEEN ABOUT THREE WEEKS NOW, BUT HER PUPIL IS STILL 5 TO 6 MM IN SIZE. HER EYE PRESSURE WAS SLIGHTLY RAISED , BUT WITH MEDICATION THEY ARE NOW 11 AND 12, THERE IS NO PUPIL IRREGULARITY. PENTACAM IMAGES SHOWED NO EVIDENCE OF IRIS OR PUPIL TUCK. PATIENT IS EXTREMELY UNHAPPY DUE TO GLARE AND HALOS, I HAVE STARTED THE PATIENT ON PILOCAR 2% EYE DROPS WITH AN ATTEMPT TO REDUCE THE PUPIL SIZE. THE SAME IS HAPPENING IN HER BOTH EYES . BOTH THE EYES VAULTING IS ABOUT 640 IN THE LEFT EYE ." IN A SEPARATE VISIT THE LENS WAS EXPLANTED 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; Halo; Intraocular Pressure Increased; Visual Disturbances
MAUDE report 21551687 ↗InjuryAug 20, 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. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 20006342 ↗InjuryAug 20, 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. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A SHORTER LENGTH LENS 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 20002617 ↗InjuryJul 25, 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 SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS REMAINS IMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19833936 ↗InjuryJun 17, 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 -8.50 AS AN EXCHANGE LENS INTO THE PATIENT'S RIGHT EYE (OD) TO RESOLVE GLARE/HALOES AND LENS DISLOCATION/SUBLUXATION ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXPLANTED. THE PROBLEM WAS RESOLVED. REPORTEDLY, "ONE SIZE UP AND IT WAS FIXED, VERTICALLY, BUT AT THE TIME OF EXAMINATION THE DAY AFTER SURGERY, IT WAS ROTATED AND FIXED HORIZONTALLY AND STILL DEVIATED DOWNWARD. SO, THE LENS WAS REMOVED." THE CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR - "SUSPECTED CILIARY BAND FRAGILITY DUE TO TRAUMA."
Patient problems: Visual Disturbances
MAUDE report 19547747 ↗MalfunctionJun 3, 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 THE SURGEON IMPLANTED A 13.2MM VICM5 13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.00 INTO THE PATIENT'S LEFT EYE (OS). REPORTEDLY "THE LENS BROKE" AND "THE LENSES HAVE BEEN EXPLANTED". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19449463 ↗InjuryMay 9, 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 -11.00D IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2024. INFORMATION ABOUT CONCOMITANT PRODUCTS USED INCLUDING OVD AND DELIVERY SYSTEM WERE NOT PROVIDED. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS DIAGNOSED. PER THE LAST REPORT DATED (B)(6) 2024, NO INFORMATION IS PROVIDED THAT THERE WAS ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED. NO LOSS OF VISUAL ACUITY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 19281573 ↗InjuryMar 18, 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, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. PATIENT DISSATISFIED WITH VISUSAL ACCUITY. LENS EXCHANGED FOR A TOIC LENS ON (B)(6) 2023 AND PROBLEM RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922745 ↗InjuryMar 18, 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, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. PATIENT DISSATISFIED WITH VISUSAL ACCUITY. LENS EXCHANGED FOR A TOIC LENS ON (B)(6) 2023 AND PROBLEM RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18922743 ↗MalfunctionNov 29, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -11.0 DIOPTER TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENT'S LEFT EYE (OS) ON 20-SEP-2023. THE LENS WAS INTRAOPERATIVELY IMPLANTED AND REMOVED. A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS USER ERROR. REPORTEDLY, THE PATIENT IS "OK" AND THE STATUS OF THE EYE IS "QUIET."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18233716 ↗InjuryOct 19, 2023Misfocusing; Misfocusing
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -11.0 DIOPTER WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO REFRACTIVE SUPRISE. ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS OTHER.
Patient problems: Blurred Vision
MAUDE report 17971404 ↗InjurySep 20, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -11.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT. REPORTEDLY, "PATIENT DOESN'T WANT TO HAVE AN EVO ICL IN ANOTHER LENGTH. SHE WERES CONTACT LENSES AGAIN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17786422 ↗MalfunctionAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -11.0 DIOPTER TORE/BROKE BEFORE INJECTION INTO THE PATIENT'S RIGHT EYE (OD). THE PROBLEM WAS NOT RESOLVED. REPORTEDLY, "THE LENS BROKE INTO 3 PIECES INSIDE THE CARTRIDGE WITH NO REASON FOR THAT. IT WAS NOT IMPLANTED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17553146 ↗MalfunctionAug 4, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -11.0 DIOPTER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS STUCK IN CARTRIDGE. THERE WAS NO PATIENT CONTACT AND NO PATIENT INJURY WAS REPORTED. A REPLACEMENT LENS WAS LATER IMPLANTED AND THE PROBLEM WAS RESOLVED. REPORTEDLY, "LENS REPLACED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17461641 ↗InjuryMay 12, 2023Inadequacy 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 -11.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED AND LATER REPLACED WITH A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. PROBLEM RESOLVED. CAUSE OF EVENT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16924380 ↗InjuryApr 27, 2023Adverse 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; -11 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. INTRAOPERATIVELY THE LENS WAS REMOVED DUE TO THE LENS WAS TORN. IT WAS NOTED THE LENS WAS DAMAGED DURING LOADING; AFTER OPENING THE VIAL; BUT DON'T REALLY KNOW WHEN THE LENS BROKE. IT WAS NOTED AN ADDITION OF NEW PI WAS ADDITIONALLY PERFORMED. A REPLACEMENT LENS WAS IMPLANTED AT A LATER DATE AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16827522 ↗InjuryMar 17, 2023Inadequacy 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 -11.00 DIOPTER WAS IMPLANTED 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 AND SIGNIFICANT REDUCTION OF IRIDOCORNEAL ANGLES. THIS EXCHANGE RESOLVED THE PROBLEM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16562713 ↗
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-0464-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0469-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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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