EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.0) (REF VICM5 13.2)Recalls & reported problems
Staar Surgical Company · VICM5 - Diopter: -5.0; 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
- 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 00841542119313), received between Sep 9, 2022 and Dec 9, 2024 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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
- Inadequacy of Device Shape and/or Size3
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 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. THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS. 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 UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878788 ↗MalfunctionJun 12, 2023No Apparent Adverse Event; No Apparent Adverse Event
THE REPORTER INDICATED THAT ON (B)(6) 2023 A 13.2MM, VICM5_13.2, -5.00 DIOPTER, IMPLANTABLE COLLAMER LENS TORE/BROKE DURING INJECTION/DELIVERY INTO THE LEFT EYE (OS). THE LENS WAS IMPLANTED,REMOVED AND REPLACED INTRAOPERATIVELY WITH NO PATIENT INJURY AND THE PROBLEM RESOLVED. CAUSE OF EVEN WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17105587 ↗InjuryFeb 20, 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 -5.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2023. THE LENS WAS REMOVED BECAUSE IT WAS "TOO LONG." LENS REPLACED WITH SHORTER. 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 16406417 ↗InjurySep 9, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT SURGEON IMPLANTED A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS WITH A -4.0 DIOPTER, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS LATER REMOVED AND REPLACED FOR A SHORTER LENGTH LENS DUE TO THE LENS BEING TOO LARGE. REPORTEDLY. "DID AN EXCHANGE LATE LAST WEEK AND THE PATIENT IS HAPPY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15395812 ↗InjurySep 9, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT SURGEON IMPLANTED A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS WITH A -4.0 DIOPTER, INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS LATER REMOVED AND REPLACED FOR A SHORTER LENGTH LENS DUE TO THE LENS BEING TOO LARGE. REPORTEDLY. "DID AN EXCHANGE LATE LAST WEEK AND THE PATIENT IS HAPPY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15393063 ↗
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-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
- Z-0468-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.
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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