Skip to content

Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102759)Recalls & reported problems

Staar Surgical Company · Diopter: -10.0; Overall Diameter (Length): 12.1 mm · Class 3 · Implant

All models of Visian ICL (Implantable Collamer Lens) (96)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542102759), received between Dec 13, 2018 and Oct 12, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Misfocusing” (2 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.

Most reported problems

Device problems

  • No Apparent Adverse Event3
  • Misfocusing2
  • Off-Label Use2
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Blurred Vision2
  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 12, 2022Misfocusing; Off-Label Use; No Apparent Adverse Event; Misfocusing; Off-Label Use; No Apparent Adverse Event

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -10.00 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018. THE LENS WILL BE REMOVED AND EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; No Clinical Signs, Symptoms or Conditions

    MAUDE report 15591791 ↗
  • InjuryOct 12, 2022Misfocusing; Off-Label Use; No Apparent Adverse Event; Misfocusing; Off-Label Use; No Apparent Adverse Event

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -10.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WILL BE REMOVED AND EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; No Clinical Signs, Symptoms or Conditions

    MAUDE report 15591731 ↗
  • MalfunctionJul 22, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 12.1MM, MICL12.1, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2019. LOW VAULT WAS OBSERVED. LENS REMAINS IMPLANTED. REPORTEDLY, THE SURGEON IS "PLANNING ON EXCHANGING LENS FOR THE NEXT SIZE UP." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10308783 ↗
  • MalfunctionDec 13, 2018No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A MICL12.1, -10.0 DIOPTER, IMPLANTABLE COLLAMER LENS WOULD NOT LOAD PROPERLY. IT WAS REPORTED THAT THERE WAS NO PATIENT CONTACT AND THE BACK-UP LENS (SERIAL NUMBER (B)(4) 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: No Patient Involvement

    MAUDE report 8159596 ↗

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, Classified
    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
  • Z-0474-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
  • Z-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
  • Z-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
  • Z-0466-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
  • Z-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page