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Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102773)Recalls & reported problems

Staar Surgical Company · Diopter: -11.0; 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
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542102773), received between Jul 19, 2017 and Aug 4, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 Problem1
  • Device Operates Differently Than Expected1
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Intraocular Pressure Increased1
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2021 A 12.1MM MICL12.1; -11.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) AS A REPLACEMENT LENS. THE SURGEON INDICATED THE PATIENT EXPERIENCED SHALLOW AC, ELEVATED INTRAOCULAR PRESSURE AND WAS TREATED WITH MEDICATIONS LIDOCAINE, MOISTAT AND MIOCHOL ALONG WITH TOPICAL PILOCARPINE. PATIENT'S ANGLES WERE STILL NARROW AND WENT ON ALPHAGAN. IT WAS ALSO NOTED THAT "SHE FEELS GOOD WITH SOME IMPROVEMENT IN HER VISION". POSTOPERATIVE REPORT INDICATED PATIENT'S IOP DECREASED TO AN ACCEPTABLE LEVEL. LENS REMAINS IMPLANTED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

    MAUDE report 12277915 ↗
  • 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, -11.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) 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 10308803 ↗
  • MalfunctionJul 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -11.0 DIOPTER WAS RETURNED TORN IN TWO PIECES. THE REPORTER STATED THAT THE CAUSE OF THE DAMAGE TO THE LENS IS UNKNOWN , COULD HAVE BEEN DAMAGE DURING LOADING. THE REPORTER STATED THAT THERE WAS NO PATIENT CONTACT, THE LENS WAS NEVER INSERTED IN THE EYE.

    Patient problems: No Patient Involvement

    MAUDE report 6727022 ↗

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-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
  • Z-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
  • Z-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
  • Z-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

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