EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-5.0) (REF VICM5 12.6)Recalls & reported problems
Staar Surgical Company · VICM5 - Diopter: -5.0; 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841542119085), received between Feb 20, 2023 and Jan 8, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
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-0465-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Delivered as Unsterile Product1
- Inadequacy of Device Shape and/or Size1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF -5.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT WITH VERY SHALLOW ANGLES. A REPLACEMENT LENS WAS IMPLANTED. 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
MAUDE report 18472279 ↗InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -5.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED AND ON (B)(6) 2023, A SMALLER LENGTH LENS WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18416996 ↗InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REPORTER INDICATED THAT 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -5.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED AND ON (B)(6) 2023, A SMALLER LENGTH LENS WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18415868 ↗MalfunctionDec 21, 2023Unintended Movement; Unintended Movement
THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -05.00 DIOPTER, DURING THE SAME SURGERY DUE TO THE LENS WAS IMPLANTED UPSIDE DOWN INTO THE PATIENTS RIGHT EYE (OD). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH A LONGER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18376661 ↗InjuryFeb 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -5.00 DIOPTER HAD STERILITY BROKEN. THE LENS HAD PATIENT CONTACT. A BACKUP LENS WAS USED. 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 16406368 ↗
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-0464-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Z-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-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 · 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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