Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102780)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542102780), received between Jan 27, 2020 and Aug 14, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2023Misfocusing; Misfocusing

  THE REPORTER INDICATED THAT A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS OF -11.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2023 THE LENS WAS EXPLANTED DUE TO REFRACTIVE SURPRISE AND LENS OPACITY. IT WAS REPORTED THAT REFRACTIVE TREATMENT AND PHACO-EMULSIFICATION WITH IOL IMPLANTATION WAS PERFORMED AND THE PROBLEM RESOLVED. THE REPORTER STATES THAT THE DEVICE FAILED TO PERFORM AS INTENDED, FOR CAUSE DETAILS THE REPORTER STATED " THE REFRACTIVE SURPRISE RESULTED IN A HYPEROPIC LVC (LASER VISION CORRECTION) AND UNSATISFACTORY VISION. THE ASC WAS OF LESSER ISSUE".

  Patient problems: Blurred Vision; Cataract

  MAUDE report 17547267 ↗
• 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; -11.5 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) 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 12278129 ↗
• InjuryApr 16, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.1MM MICL12.1, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE ON (B)(6) 2020. ON (B)(6) 2020 THE LENS WAS REMOVED DUE TO EXCESSIVE VAULT. CAUSE OF THE EVENT IS REPORTED AS PATIENT RELATED FACTOR. REPORTEDLY, SURGEON "BELIEVED THE ANATOMY OF THE SULCUS DID NOT ALLOW FOR AN IDEAL PLACEMENT. SOME BLURRED VISION AT 1 DAY POST UP. NO PAIN. PLANNED LVC (LASER VISION CORRECTION) IN 6 WEEKS."

  Patient problems: No Code Available

  MAUDE report 9967630 ↗
• MalfunctionJan 27, 2020Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT A 12.1MM, MICL12.1, -11.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019 AS A REPLACEMENT LENS DUE TO EXCESSIVE VAULT, GLARE/HALOES AND BLURRED VISION. IT WAS REPORTED THAT THE LENS RESOLVED THE PROBLEM BUT THE PATIENT HAD SOME ISSUES OF GLARE AT NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. REFERENCE MFR# 2023826-2020-00203 FOR INITIAL LENS.

  Patient problems: Visual Disturbances

  MAUDE report 9634784 ↗

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-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-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.