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Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102827)Recalls & reported problems

Staar Surgical Company · Diopter: -13.5; 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841542102827), received between May 26, 2017 and May 26, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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

  • Positioning Failure1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 26, 2017Positioning Failure; Positioning Failure

    THE REPORTER INDICATED THE SURGEON INSERTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -13.5 DIOPTER, AND THE LENS WAS NOTED TO HAVE FLIPPED. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE IRIS HAD COME DOWN SO THE SURGEON DECIDED TO BRING THE PATIENT BACK ON (B)(6) 2017 TO IMPLANT THE BACKUP LENS. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN. THE REPORTER INDICATED THEY USED ANOTHER MANUFACTURERS INJECTOR SYSTEM WITH THIS MODEL LENS AND THIS IS OFF-LABEL USE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6595991 ↗

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-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-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
  • Z-0469-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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