EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-10.5) (REF VICM5 13.2)Recalls & reported problems
Staar Surgical Company · VICM5 - Diopter: -10.5; 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 sizing and focus problems such as too much space behind the lens, raised eye pressure, glare and incorrect correction, often needing the lens to be removed or exchanged. Of 23 reports naming its identifier, there were no deaths and 12 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
- 23
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00840311300945), received between Dec 1, 2022 and Mar 11, 2026 — classified as 12 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Off-Label Use” (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
- No Apparent Adverse Event11
- Adverse Event Without Identified Device or Use Problem9
- Off-Label Use3
- Inadequacy of Device Shape and/or Size2
- Misfocusing1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Intraocular Pressure Increased2
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 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. IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A TORIC LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS 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 24569789 ↗InjuryJun 25, 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 AN EXCESSIVE VAULT AND PUPIL IMPAIRMENT. IN A SEPARATE VISIT THE LENS WAS EXPLANTED AND ON THE SAME DAY BUT DIFFERENT SURGERY THE LENS WAS REPLACED WITH A SHORTER LENGTH LENS WITH A DIFFERENT POWER AND THE PROBLEM WAS MARKED AS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS OTHER, "ICL OVERSIZED, ON EXCHANGE THE VAULT HAS IMPROVED TO A 1CT, BUT SAME TEMPORAL IRIS SPHINCTER ATROPHY REMAINS." 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. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22325474 ↗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 530 IN THE RIGHT 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 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; Halo; Intraocular Pressure Increased; Visual Disturbances
MAUDE report 21551026 ↗InjuryFeb 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 COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES. THE LENS WAS LATER REMOVED AND REPLACED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT WAS REPORTED AS THE DEVICE. NORMAL ANTERIOR CHAMBER DEPTH RESTORED, AND INITIAL CROWDING OF IRIDO-CORNEAL ANGLES RESOLVED AFTER EXCHANGING ICL WITH A SMALLER SIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334400 ↗InjuryNov 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 A REFRACTIVE SURPRISE. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR THE SAME SIZE DIFFERENT POWER. THE PROBLEM WAS RESOLVED. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 20761819 ↗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 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: Intraocular Pressure Increased
MAUDE report 20251620 ↗InjuryJul 23, 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. IN A SEPARATE VISIT THE LENS WAS EXPLANTED. THE PROBLEM WAS NOT RESOLVED. FOLLOW-UP TREATMENT PLANNED. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 1 OF 2 TOTAL REPORTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19805168 ↗InjuryMay 1, 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, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2024 DUE TO EXCESSIVE VAULT. A SHORTER LENGTH LENS WAS IMPLANTED IN A SECOND SURGERY ON (B)(6) 2024. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS OTHER: WTW BETWEEN SIZES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226719 ↗MalfunctionApr 10, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.50 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. THE LENS REMAINS IMPLANTED. REPORTEDLY, "THEY WILL NOT DO ANYTHING AND MONITOR THE CASE. LENS WILL NOT BE REMOVED." THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081427 ↗MalfunctionApr 9, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -10.50 INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. THE PATIENT EXPERIENCED EXCESSIVE VAULTING. THE LENS REMAINS IMPLANTED. REPORTEDLY, "THEY WILL NOT DO ANYTHING AND MONITOR THE CASE. LENS WILL NOT BE REMOVED." THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19074222 ↗MalfunctionMar 8, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -10.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024 AND THE PATIENT EXPERIENCED EXCESSIVE VAULT. IT WAS REPORTED THAT MEDICAL OR SURGICAL INTERVENTION IS NOT NECESSARY. REPORTER STATED THAT THE PATIENT IS HAPPY AND THE DOCTOR WILL MONITOR CLOSELY. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18867245 ↗MalfunctionFeb 9, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -10.5 DIOPTER LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FROM THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024, DUE TO A LENS TEAR/BREAK DURING LOADING AND THE LENS BEING STUCK IN CARTRIDGE OR INJECTION SYSTEM. THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT INJURY. CAUSE OF THE EVENT WAS THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18673920 ↗MalfunctionJan 22, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2 -10.50 DIOPTER IMPLANTABLE COLLAMER LENS TORE/BROKE 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 18560168 ↗MalfunctionNov 21, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -10.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. INTRAOPERATIVELY THE LENS WAS REMOVED WITH NO PATIENT INJURY. ON (B)(6) 2023 A REPLACEMENT LENS WAS OF THE SAME LENGTH WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18188683 ↗InjuryOct 3, 2023Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2, -10.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REPLACED WITH A LONGER LENGTH LENS DUE TO LOW VAULT ON (B)(6) 2023. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR, LENS TOO SHORT. REPORTEDLY, VAULT AND NEAR VISION IMPROVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17862045 ↗MalfunctionSep 14, 2023Off-Label Use; No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -10.50 DIOPTER TORE DURING INJECTION/DELIVERY INTO THE EYE. THE LENS WAS INTRAOPERATIVELY IMPLANTED, REMOVED, AND REPLACED FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17750466 ↗InjurySep 1, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, IN THE PATIENTS LEFT EYE (OS), ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023 DUE TO THE LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE EYE. THERE WAS NO PATIENT INJURY. 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 17672650 ↗InjuryMay 1, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -10.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS HAD TORE DURING INJECTION/DELIVERY INTO THE EYE. INTRAOPERATIVELY THE LENS AS REMOVED WITH NO PATIENT INJURY. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16850167 ↗MalfunctionApr 12, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT ON (B)(6) 2023 A 13.2MM, VICM5_13.2, -10.50 DIOPTER, IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE RIGHT EYE (OD). THE LENS WAS IMPLANTED AND REMOVED INTRAOPERATIVELY WITH NO PATIENT INJURY. A REPLACEMENT LENS WAS IMPLANTED AT A LATER DATE AND THE PROBLEM RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16727226 ↗MalfunctionMar 22, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, WITHIN THE SAME SURGERY DUE TO THE LENS WAS TORN BEFORE LOADING. THE REPORTER INDICATED THE LENS WAS RECEIVED WITH A SMALL TEAR. AS THE LENS WAS BEING INJECTED INTO THE ANTERIOR CHAMBER, THE LENS CAME OUT FROM THE INJECTOR ALREADY BROKEN. THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16595141 ↗InjuryMar 10, 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 -10.5 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS EXCHANGED ON (B)(6) 2022 FOR A SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT. THIS RESOLVED THE PROBLEM. THE REPORTER DID NOT INDICATE THE CAUSE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16519999 ↗MalfunctionDec 9, 2022Misfocusing; Misfocusing
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -10.50 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT HAS "WRONG REFRACTION" (OVER CORRECTION). LENS REMAINS IMPLANTED. THE CAUSE OF THE EVENT WAS REPORTED AS USER ERROR AND NOTED THE DEVICE FAILED TO PERFORM AS INTENDED; "WRONG INITIAL REFRACTION".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15955610 ↗MalfunctionDec 1, 2022No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2; -10.50 DIOPTER IMPLANTABLE COLLAMER LENS; WHICH WAS INTENDED FOR THE PATIENT'S RIGHT EYE (OD); HAD TORE DURING LOADING. THIS OCCURRED ON (B)(6) 2022. THERE WAS NO PATIENT CONTACT. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15898870 ↗
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-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-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.
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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