Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103169)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542103169), received between Oct 28, 2016 and Aug 19, 2020 — classified as 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2020Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED UPSIDE DOWN A 13.2MM MICL13.2, -3.5 DIOPTER, IMPLANTABLE COLLAMER LENS, INTO THE PATIENT'S LEFT EYE ON (B)(6) 2020. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS REMOVED AND EXCHANGED ON (B)(6) 2020 WITH A SAME SIZE, SIMILAR (SPHERE/CYLINDER/AXIS) LENS. THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS REPORTED AS USER ERROR. REPORTEDLY, SURGEON "DID NOT RECOGNIZE THAT LENS WAS IMPLANTED UPSIDE DOWN AT SURGERY, BUT IT WAS EVIDENT AT THE ONE-WEEK POST-OP VISIT."

  Patient problems: No Code Available

  MAUDE report 10426599 ↗
• MalfunctionDec 20, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A 13.2 MM, MICL13.2, -3.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IN THE PROCESS OF BEING IMPLANTED, BUT IT WOULD NOT UNFOLD CORRECTLY OUT OF THE CARTRIDGE WHEN IT WAS PARTIALLY IMPLANTED IN THE EYE. THE LENS WAS THEN REMOVED IN ORDER TO RELOAD IT INTO THE CARTRIDGE AGAIN, WHEN IT WAS NOTED THAT IT WAS EXPIRED. THE BACKUP LENS WAS THEN OPENED AND IMPLANTED DURING THE SAME SURGERY. PER REPORTER THE BACK UP LENS UNFOLDED PERFECTLY. CAUSE OF EVENT WAS UNKNOWN. THE REPORTED STATED THAT THERE WAS NO INJURY TO THE PATIENT, CURRENTLY 20/20 AND HAPPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8186162 ↗
• InjuryOct 28, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -3.5 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE REPORTER INDICATED AT THE TIME OF SURGERY, THE PUPIL WAS AT A MINIMAL DILATION OF 8MM AND THE ICL WAS EXTREMELY VAULTED IN THE ANTERIOR CHAMBER, SO THE SURGEON DECIDED TO REMOVE THE LENS DURING THE SAME SURGERY. THE LENS WAS EXCHANGED FOR A SHORTER LENS. THERE WAS CORNEAL EDEMA AT ONE DAY POST-OP. VISION WAS 20/20.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 6064998 ↗

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-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• 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-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.