EVO/EVO+VISIAN Implantable Collamer Lens VICMO 13.2 (-15.0) (REF VICMO 13.2)Recalls & reported problems
Staar Surgical Company · VICMO - Diopter: -15.0; 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
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840311302512), received between Nov 21, 2023 and Sep 29, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Adverse Event Without Identified Device or Use Problem3
- Inadequacy of Device Shape and/or Size3
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse 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 with significant reduction of iridocorneal angles and significant shallowing of the AC, cloudy vision and refractive surprise. Lens was exchanged for a shorter length lens and problem was resolved. Cause of the event was reported as unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937370 ↗InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MEDICAL PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE VAULT AND REFRACTIVE SURPRISE. REPORTEDLY, "HIGHER THAN EXPECTED VAULT AND RESIDUAL HYPEROPIA". IN A SEPARATE SURGERY THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL/ POWER, SHORTER LENGTH AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: Blurred Vision
MAUDE report 23397388 ↗InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED WITH A SAME LENGTH BUT DIFFERENT MODEL AND POWER AND THE PROBLEM RESOLVED. THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN.
Patient problems: Blurred Vision
MAUDE report 21542998 ↗InjuryMar 1, 2024Off-Label Use; Inadequacy of Device Shape and/or Size; Off-Label Use; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS, -15.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD), ON (B)(6) 2023. THE LENS WAS EXPLANTED ON (B)(6) 2023, DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18820160 ↗InjuryJan 14, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -15.0 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. THIS RESOLVED THE PROBLEM. CAUSE REPORTED AS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18509893 ↗InjuryNov 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICMO13.2 IMPLANTABLE COLLAMER LENS OF DIOPTER -15.0 INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. EXCESSIVE VAULT AND SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES WERE REPORTED. THE LENS WAS EXCHANGED ON (B)(6) 2023 FOR A SHORTER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF EVENT REPORTED AS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18180594 ↗
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-0466-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. 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-0467-2024 · Sep 29, 2023 · Open, ClassifiedEVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
- Z-0465-2024 · Sep 29, 2023 · Open, ClassifiedEVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
- Z-0474-2024 · Sep 29, 2023 · Open, ClassifiedEVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page