Visian ICL (Implantable Collamer Lens) MICL 12.1 (UDI 00841542102803)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841542102803), received between Aug 4, 2017 and Jan 27, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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

Recent adverse event reports

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

• MalfunctionJan 27, 2020Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT A 12.1MM, MICL12.1, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2018 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# 2023826-2020-00202 FOR INITIAL LENS.

  Patient problems: Visual Disturbances

  MAUDE report 9634639 ↗
• MalfunctionMay 2, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A 12.1MM, MICL12.1, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2019 AS A REPLACEMENT LENS DUE TO EXCESSIVE VAULT. THIS EXCHANGE RESOLVED THE PROBLEM BUT MILD INFLAMMATION WAS OBSERVED AT PATIENTS LAST FOLLOW UP VISIT, BCVA:20/40.2, UCVA: 30/40.2, VAULT:500 AND IOP 12MMHG. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Inflammation

  MAUDE report 8575012 ↗
• InjuryJun 28, 2018Positioning Failure; Inadequacy of Device Shape and/or Size; Positioning Failure; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THAT A 12.1MM, MICL12.1, -12.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) UPSIDE DOWN, THE LENS WAS REMOVED AND THE BACKUP LENS WAS USED. THE REPORTER STATED THAT THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7648241 ↗
• InjuryAug 4, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON IMPLANTED A 12.1MM MICL12.1 IMPLANTABLE COLLAMER LENS, -12.5 DIOPTER. IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. ONE WEEK AFTER THE LENS WAS IMPLANTED, THE LENS HAD SOME RESIDUAL VAULTING. THE PRESSURE WAS GOOD, SO THE SURGEON AUGMENTED THE PERIPHERAL IRIDECTOMIES. THE VAULT AND PATIENT WERE FINE AND THE LENS REMAINS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 6767809 ↗

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