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Visian ICL (Implantable Collamer Lens) MCL 12.1Recalls & reported problems

Staar Surgical Company · Diopter: -7.5; 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
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841542102704), received between Nov 16, 2018 and May 25, 2022 — classified as 1 injury, 1 malfunction.

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 Event2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 25, 2022No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 12.1MM MICL 12.1 IMPLANTABLE COLLAMER LENS OF -7.5 DIOPTER WAS CAUGHT WITHIN CARTRIDGE AS THE DOCTOR WAS ADVANCING THE LENS, THE LENS RIPPED ON (B)(6) 2022. THERE WAS PATIENT CONTACT BUT THE LENS WAS NOT IMPLANTED. A BACKUP LENS WAS USED FOR THE IMPLANTATION IN THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14493202 ↗
  • MalfunctionNov 16, 2018No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THE SURGEON WAS INSERTING A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, THE PATIENT MOVED AND THE LENS BENT UPWARDS. THE LENS WAS PARTIALLY INSERTED AND WAS REMOVED DURING THE SAME SURGERY, WITH NO PATIENT INJURY. THE SURGEON WAS NOT SURE IF THE LENS WAS DAMAGED, SO DECIDED TO IMPLANT THE BACKUP LENS WITH NO PROBLEM. THE SURGEON STATED THE CAUSE OF THE EVENT WAS PATIENT RELATED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8081339 ↗

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-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-0465-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. 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-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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