EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-11.0) (REF VICM5 12.6)Recalls & reported problems
Staar Surgical Company · VICM5 - Diopter: -11.0; 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 inside the eye to correct vision. The 24 reports mostly describe blurred vision, glare and halos, and lenses sitting poorly or shifting out of place, sometimes needing repositioning or replacement, plus lenses sticking during implantation. The reports mention no deaths and 13 injuries. 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
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00840311300624), received between Feb 13, 2023 and Sep 24, 2026 — classified as 14 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 Problem10
- No Apparent Adverse Event10
- Inadequacy of Device Shape and/or Size5
- Off-Label Use2
- Improper or Incorrect Procedure or Method1
- Misfocusing1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Blurred Vision5
- Visual Disturbances2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cataract1
- Halo1
- Inflammation1
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50889584 ↗InjuryMar 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 DOUBLE VISION, GLARES/HALOES, BLURRED VISION, AND LENS DECENTRATION. THE LENS WAS REPOSITIONED. CAUSE OF THE EVENT WAS REPORTED AS OTHER. 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: Blurred Vision
MAUDE report 24521517 ↗InjuryMar 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 DOUBLE VISION, GLARES/HALOES, BLURRED VISION, AND LENS DECENTRATION. THE LENS WAS REPOSITIONED. CAUSE OF THE EVENT WAS REPORTED AS OTHER. 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: Blurred Vision
MAUDE report 24521513 ↗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 KERATITIS. MEDICATION WAS ADMINISTERED. THE LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS UNKNOWN.
Patient problems: Inflammation
MAUDE report 23518635 ↗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 A LOW VAULT, REFRACTIVE CHANGE OVER TIME, GLARES/ HALOES, BLURRED VISION AND DECREASED VISUAL ACUITY. IN A SEPARATE SURGERY THE LENS WAS EXPLANTED AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS A PATIENT RELATED FACTOR. 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: Blurred Vision; Halo; Visual Disturbances
MAUDE report 23459453 ↗InjuryFeb 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) PROCEDURE THE PATIENT EXPERIENCED LOW VAULTING AND BLURRED VISION WITH CATARACT DEVELOPMENT. THE LENS WAS EXCHANGED AND PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS 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; Cataract
MAUDE report 21415438 ↗MalfunctionDec 4, 2024No Apparent Adverse Event; No Apparent Adverse Event
A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS (ICL) BECAME STUCK IN THE CARTRIDGE. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY. THE LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FOR A REPLACEMENT LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20845792 ↗InjuryNov 5, 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 LENS FAILED TO OPEN WITHIN THE ANTERIOR CHAMBER, MAKING MANIPULATION DIFFICULT. THIS DIFFICULTY LED TO IRIS BLEEDING AND RESULTED IN THE LENS MAKING CONTACT WITH THE ANTERIOR LENS CAPSULE DURING THE REMOVAL MANEUVER. THE LENS WAS REMOVED DURING THE SAME SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613731 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6M VICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.0 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. ON (B)(6) 2024 THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS DUE TO GLARE/HALOES AND LENS DISLOCATION/SUBLUXATION. THE PROBLEM WAS NOT 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." THE CAUSE OF THE EVENT WAS REPORTED AS PATIENT RELATED FACTOR - "SUSPECTED CILIARY BAND FRAGILITY DUE TO TRAUMA."
Patient problems: Visual Disturbances
MAUDE report 19464132 ↗MalfunctionMay 15, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -11.00 DIOPTER, WAS STUCK IN THE CARTRIDGE OR INJECTION SYSTEM AND WAS DAMAGED. THERE WAS NO PATIENT CONTACT. 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 19322968 ↗InjuryApr 3, 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 -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT UNDERWENT SAME DAY BILATERAL ICL IMPLANTATION. OPEGAN OVD WAS USED INTRAOPERATIVELY. TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS OBSERVED BILATERALLY SAME DAY UPON LENS IMPLANTATION. INFLAMMATION WAS CONFIRMED BY OCT IMAGING. IN THE REPORTER'S OPINION, THE CAUSE IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. THE LENS REMAINS IMPLANTED.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 19030995 ↗MalfunctionMar 28, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT ON (B)(6) 2024 A 12.6MM, VICM5_12.6, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS STUCK IN CARTRIDGE OR INJECTION SYSTEM. INTRAOPERATIVELY THE LENS WAS REMOVED AND REPLACED WITH NO PATIENT INJURY AND THE PROBLEM RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18997598 ↗MalfunctionMar 19, 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 -11.0 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. INTRAOPERATIVELY THE LENS WAS REMOVED DUE TO THE LENS WAS IMPLANTED UPSIDE DOWN. THERE WAS PATIENT CONTACT BUT NO PATIENT INJURY. ON 15-DEC-2023 A REPLACEMENT LENS OF THE SAME MODEL, LENGTH WAS IMPLANTED. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18937949 ↗MalfunctionMar 6, 2024Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
THE REPORTER INDICATED A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -11.0 DIOPTER, TORE/BROKE DURING LOADING. ON (B)(6) 2023, A REPLACEMENT LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS A USER ERROR, WITH THE DEVICE NOT FAILING TO PERFORM AS INTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18853003 ↗MalfunctionJan 9, 2024Inadequacy 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, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS FROM THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. LOW VAULT WAS OBSERVED. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18473803 ↗MalfunctionDec 21, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT ON (B)(6) 2023 A 12.6MM, VICM5_12.6, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING. THERE WAS NO PATIENT CONTACT. A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18378882 ↗InjuryOct 15, 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 -11.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17937005 ↗MalfunctionOct 3, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED, REMOVED, AND REPLACED WITH A SAME LENGTH LENS INTRAOPERATIVELY ON (B)(6) 2023 FROM PATIENT'S RIGHT EYE (OD) DUE TO LENS TEAR/BREAK DURING LOADINGT. THIS RESOLVED THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862039 ↗InjuryAug 20, 2023Misfocusing; Misfocusing
THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6 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 DIFFERENT POWER LENS DUE TO TRANSIENT LOSS OF BCVA . THE EXCHANGE RESOLVED THE PROBLEM. CAUSE IS REPORTED AS UNKNOWN.
Patient problems: Blurred Vision
MAUDE report 17581262 ↗InjuryJun 20, 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 -11.0 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2023 DUE TO EXCESSIVE VAULT. IN A SEPARATE SURGERY THAT DAY A SHORTER LENGTH LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17160355 ↗InjuryJun 7, 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 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -11.0 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. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT GIVE A CAUSE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17084048 ↗MalfunctionMay 16, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -11.00 DIOPTER, TORE BEFORE LOADING AND THERE WAS NO PATIENT CONTACT. 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 16942482 ↗MalfunctionMar 3, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT ON (B)(6) 2022 A 12.6MM, VICM5_12.6, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE PATIENTS LEFT (OS) EYE. THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY WITH NO PATIENT INJURY. A REPLACEMENT LENS WAS LATER IMPLANTED AND THE PROBLEM RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16482513 ↗InjuryMar 2, 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 -11.0 DIOPTER WAS IMPLANTED INTO THE RIGHT EYE (OD) OF A PATIENT WITH PRE-EXISTING MYOPIA ON (B)(6) 2023. ON (B)(6) 2023, THE LENS WAS REMOVED DUE TO A LENS TEAR/BREAK DURING BEFORE/DURING AND DURING INJECTION/DELIVERY INTO THE EYE. IN A SUBSEQUENT SURGERY LATER THAT DAY, A REPLACEMENT LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED. THERE WAS PATIENT CONTACT, BUT NO PATIENT INJURY. REPORTEDLY, STATUS OF THE EYE IS "RIGHT EYE PHACKIC WITHOUT ICL" AND "BROKEN PIECE WAS REMOVED. SURGERY RESCHEDULED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16471631 ↗MalfunctionFeb 13, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED, REMOVED, AND REPLACED INTRAOPERATIVELY WITH A SHORTER LENGTH LENS ON (B)(6) 2022 FROM PATIENT'S RIGHT EYE (ID) DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16364163 ↗
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-0469-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- 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-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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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