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Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103206)Recalls & reported problems

Staar Surgical Company · Diopter: -5.5; Overall Diameter (Length): 13.2 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
9
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841542103206), received between Sep 20, 2016 and Jan 11, 2022 — classified as 6 injuries, 3 malfunctions.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3
  • Inadequacy of Device Shape and/or Size3
  • No Apparent Adverse Event2
  • Torn Material1

Patient problems

  • No Code Available3
  • Cataract2
  • Intraocular Pressure Increased2
  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 11, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -05.50 DIOPTER, TORE DURING THE LOADING PROCESS AND THERE WAS NO PATIENT CONTACT. THE LENS WAS REPLACED WITH ANOTHER ICL LENS AND THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT WAS DUE TO USER ERROR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13232925 ↗
  • InjuryJun 4, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2, -5.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULT ON (B)(6) 2021. THIS RESOLVED THE PROBLEM.CAUSE OF THE EVENT IS REPORTED AS DEVICE. REPORTEDLY, OBJECTIVE SLE: TRACE DMF.

    Patient problems: Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

    MAUDE report 11939033 ↗
  • InjuryApr 1, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2020. ON THE SAME DATE, IN A SEPARATE SURGERY, THE SURGEON EXCHANGED THE LENS WITH A SHORTER LENS DUE TO EXCESSIVE VAULT. THE PROBLEM WAS RESOLVED. THE CAUSE OF THE EVENT IS REPORTED AS DEVICE "(SIZE)."

    Patient problems: No Code Available

    MAUDE report 9910954 ↗
  • InjuryDec 9, 2019Adverse 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 MICL13.2 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, INTO THE PATIENT'S RIGHT (OD) EYE. REPORTEDLY, THE PATIENT DEVELOPED A CATARACT. IT IS UNKNOWN AS TO WHETHER THE LENS REMAINS IMPLANTED; ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

    Patient problems: Cataract

    MAUDE report 9441184 ↗
  • InjuryDec 9, 2019Adverse 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 MICL13.2 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, INTO THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2018. REPORTEDLY, THE PATIENT DEVELOPED A CATARACT. IT IS UNKNOWN AS TO WHETHER THE LENS REMAINS IMPLANTED; ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

    Patient problems: Cataract

    MAUDE report 9441180 ↗
  • MalfunctionSep 3, 2019No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -5.5 DIOPTER, IMPLANTABLE COLLAMER LENS NOTICED TO BE TORN BEFORE VIAL WAS OPENED ON (B)(6) 2019. THERE WAS NO PATIENT CONTACT. BACK-UP LENS WAS IMPLANTED AND PROBLEM RESOLVED. PER THE REPORTER ON (B)(6) 2019, "UPON OPENING THE PACKAGE, THE SURGEON NOTICED LOOKING THROUGH THE VIAL THAT THE LENS WAS TORN."

    Patient problems: No Patient Involvement

    MAUDE report 8957661 ↗
  • InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, LENS WAS RECEIVED RETURNED WITH A NOTE, "EXPLANTED LENS" ON IT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

    Patient problems: No Code Available

    MAUDE report 7870377 ↗
  • InjuryDec 13, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING AND ANGLE CLOSURE. THE PERIPHERAL IRIDOTOMIES WERE ENLARGED. THE LENS WAS EXCHANGED FOR A SHORTER LENS.

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 6172497 ↗
  • MalfunctionSep 20, 2016Torn Material; Torn Material

    THE REPORTER STATED THE SURGICAL COORDINATOR ATTEMPTED TO PULL A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -5.5 DIOPTER, DOWN THROUGH THE CARTRIDGE BARREL AND NOTED THE LENS WAS TORN. THE REPORTER DECIDED NOT TO CONTINUE WITH THIS LENS AND THERE WAS NO PATIENT CONTACT. THE BACKUP LENS WAS LOADED AND IMPLANTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5965488 ↗

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-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-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.
  • Z-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
  • Z-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
  • Z-0474-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

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