EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0) (REF VICM5 13.2)Recalls & reported problems
Staar Surgical Company · VICM5 - Diopter: -8.0; 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841542119375), received between Sep 22, 2022 and Oct 10, 2024 — classified as 7 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Misfocusing” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
7 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
Recalls naming this device
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0466-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- No Apparent Adverse Event5
- Misfocusing2
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Blurred Vision2
- Intraocular Pressure Increased1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 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 LENS ROTATION. IN A SEPARATE VISIT THE LENS WAS EXCHANGED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. 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 20424815 ↗MalfunctionAug 14, 2024No Apparent Adverse Event; No Apparent Adverse Event
A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE LENS WAS REPLACED WITH A LONGER LENGTH LENS. THE INITIAL LENS WAS IMPLANTED, REMOVED AND REPLACED INTRAOPERATIVELY. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT WAS REPORTED AS OTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19987500 ↗InjuryFeb 27, 2024Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -8.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. REFRACTIVE SURPRISE WAS OBSERVED. LENS REMAINS IMPLANTED.CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: Blurred Vision
MAUDE report 18788747 ↗InjuryFeb 27, 2024Misfocusing; Adverse Event Without Identified Device or Use Problem; Misfocusing; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -8.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. REFRACTIVE SURPRISE WAS OBSERVED. LENS REMAINS IMPLANTED. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.
Patient problems: Blurred Vision
MAUDE report 18788746 ↗MalfunctionSep 7, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -8.0 DIOPTER TORE ON IMPLANTATION. THERE WAS PATIENT CONTACT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17704643 ↗InjuryAug 25, 2023Adverse 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 IMPLANTABLE COLLAMER LENS OF -8.00 DIOPTER WAS EXPLANTED ON (B)(6) 2023, FOR AN UNKNOWN REASON. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17627998 ↗InjuryAug 25, 2023Adverse 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 IMPLANTABLE COLLAMER LENS OF -8.00 DIOPTER WAS EXPLANTED ON (B)(6) 2023 FOR AN UNKNOWN REASON. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17627940 ↗InjuryAug 20, 2023Adverse 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 IMPLANTABLE COLLAMER LENS OF -8.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) .ELEVATED IOP WAS OBSERVED. IT WAS REPORTED THAT ON (B)(6) 2023 THE LENS WAS ROTATED VERTICALLY AND THE PROBLEM RESOLVED. SURGEON STATES " DOING GREAT, OFF ALL DROPS". CAUSE OF EVENT WAS UNKNOWN.
Patient problems: Intraocular Pressure Increased
MAUDE report 17581257 ↗MalfunctionJul 27, 2023Adverse 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 A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -8.00 DIOPTER WAS IMPLANTED AND HAD TO BE EXPLANTED DUE TO THE LENS' FOOTPLATE TEARING DURING THE IMPLANTATION PROCESS (MOST LIKELY FROM THE GRASPER THROUGH THE LENS CARTRIDGE). DOCTOR THEN OPENED THE BACK-UP LENS AND IMPLANTED IT INSTEAD. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17410913 ↗InjuryJun 30, 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, -08.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO BEING TOO BIG. 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 17241666 ↗MalfunctionApr 20, 2023Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -8.0 DIOPTER WAS DAMAGED DURING DELIVERY INTO THE EYE. THE LENS WAS IMPLANTED AND THE LENS TWISTED. IT WAS REMOVED AND THE REPLACEMENT LENS WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777713 ↗MalfunctionSep 22, 2022No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF -8.0 DIOPTER WAS TORN DURING LOADING. NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15467932 ↗
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-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- 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.
Other Lens, Intraocular, Phakic devices
- 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
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-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 · each recall links to the FDA recall notice
- 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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