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Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103374)Recalls & reported problems

Staar Surgical Company · Diopter: -14.0; 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
12
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841542103374), received between Jul 12, 2016 and Apr 26, 2022 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
  • Device Operates Differently Than Expected3
  • Inadequacy of Device Shape and/or Size3
  • No Apparent Adverse Event3
  • Misfocusing1
  • Off-Label Use1
  • Patient-Device Incompatibility1
  • Torn Material1

Patient problems

  • Intraocular Pressure Increased4
  • No Clinical Signs, Symptoms or Conditions3
  • No Code Available3
  • No Consequences Or Impact To Patient2
  • No Patient Involvement2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Missing Value Reason1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 26, 2022Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -14.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE LENS WAS EXPLANTED ON (B)(6) 2022 DUE TO REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14215070 ↗
  • InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

    THE REPORTER INDICATED THAT A 13.2MM MICL 13.2 OF -14.0 DIOPTER LENS TORE IN THE INJECTOR. "BACKUP LENS WAS USED". NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14165102 ↗
  • MalfunctionOct 14, 2020No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT ON (B)(6) 2020 A MICL 13.2, -14.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE BEFORE/DURING LOADING. NO PATIENT CONTACT. A BACKUP LENS WAS IMPLANTED INTRAOPERATIVELY AND THIS RESOLVED THE PROBLEM. PER REPORTER ON (B)(6) 2020, "PATIENT IS DOING WELL."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10678695 ↗
  • InjurySep 15, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -14.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO HIGH PRESSURE. THE LENS WAS EXCHANGED FOR A DIFFERENT SIZE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

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

    MAUDE report 10537758 ↗
  • InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE REPORTER INDICATED THAT 13.2MM, MICL13.2, -14.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED ON (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019 DUE TO ELEVATED PRESSURE THAT COULD NOT BE RESOLVED WITH ADDITIONAL PI'S AND MEDS.ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 9152716 ↗
  • MalfunctionOct 9, 2018No Apparent Adverse Event; No Apparent Adverse Event

    THE REPORTER INDICATED THAT THE ANTERIOR LEAFLET OF A MICL13.2, -14.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING LOADING ON (B)(6) 2018, WITH NO PATIENT CONTACT. THE BACKUP LENS IMPLANTED DURING INITIAL SURGERY WITH NO PATIENT INJURY. PROBLEM RESOLVED.

    Patient problems: No Patient Involvement

    MAUDE report 7947525 ↗
  • InjurySep 13, 2018Inadequacy 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, -14.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXCHANGED ON (B)(6) 2018 WITH A SHORTER LENGTH LENS DUE TO PUPIL BLOCK WITH ELEVATED IOP (INTRAOCULAR PRESSURE), TOO LARGE LENS WITH AC SHALLOWING, HIGH VAULTING AND NARROWING OF ANGLE. THIS EXCHANGE RESOLVED THE PROBLEM.

    Patient problems: Intraocular Pressure Increased; Missing Value Reason

    MAUDE report 7875111 ↗
  • MalfunctionDec 12, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    THE REPORTER INDICATED THAT A 13.2 MM MICL13.2 LENS, DIOPTER -14.0 WAS TO BE EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2017, POSSIBLY DUE TO AN OVER VAULT. ATTEMPTS TO OBTAIN ADDITIONAL OR UPDATED INFORMATION HAVE BEEN UNSUCCESSFUL.

    Patient problems: No Code Available; No Known Impact Or Consequence To Patient

    MAUDE report 7109937 ↗
  • MalfunctionJul 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER STATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -14.0 TORE DURING THE LOADING PROCESS. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

    Patient problems: No Patient Involvement

    MAUDE report 6727148 ↗
  • InjuryApr 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER STATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -14.0 DIOPTER, WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS WITHIN THE SAME SURGERY BECAUSE IT WAS CAUSING PRESSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Patient problems: Intraocular Pressure Increased; No Code Available

    MAUDE report 6524681 ↗
  • MalfunctionJan 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE REPORTER STATED THAT A MICL13.2, -14.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED. THE SURGEON NOTICED THE LENS WAS DAMAGED AFTER IT WAS IMPLANTED. THE LENS WAS REMOVED AND THE BACK UP LENS WAS IMPLANTED WITH NO ISSUES. THE REPORTED STATED THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6291276 ↗
  • MalfunctionJul 12, 2016Torn Material; Torn Material

    THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -14.0 DIOPTER, IN THE PATIENT'S EYE AND THE HAPTIC BROKE. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER STATED THE CAUSE OF THE EVENT WAS DUE TO THE SURGEON IMPROPERLY LOADED THE LENS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5788410 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
    EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
  • 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-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-0468-2024 · Sep 29, 2023 · Open, Classified
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
  • Z-0464-2024 · Sep 29, 2023 · Open, Classified
    EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.

Other Lens, Intraocular, Phakic devices

All Lens, Intraocular, Phakic devices →

Sources and updates

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