Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103510)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542103510), received between Apr 12, 2017 and Sep 14, 2022 — 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.

• InjurySep 14, 2022Off-Label Use; Off-Label Use

  THE REPORTER INDICATED THAT A 13.7MM MICL 13.7 IMPLANTABLE COLLAMER LENS OF -7.50 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON 13-MAY-2022. ON 06-JUN-2022 THE LENS WAS EXPLANTED DUE TO PUPIL BLOCK WITH ELEVATED IOP; ANGLE CLOSURE WITH ELEVATED IOP; ADDITION OF NEW PI. REPORTEDLY THE PROBLEM WAS RESOLVED. "PATIENT REFUSED TO HAVE A REPLACEMENT ICL IMPLANTED. WILL CONSIDER LASIK OR PRK IN FUTURE." CAUSE REPORTED AS DEVICE.

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

  MAUDE report 15423696 ↗
• InjuryOct 5, 2017Shelf Life Exceeded; Inadequacy of Device Shape and/or Size; Shelf Life Exceeded; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL13.7, -7.5 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO INTERMITTENT ELEVATED IOP, HEADACHES, EXCESSIVE VAULTING, NARROWING OF THE ANGLE, AND SHALLOWING OF THE ACD. THE LENS WAS EXCHANGED WITH A NEW LENS.

  Patient problems: Headache; Intraocular Pressure Increased; No Code Available

  MAUDE report 6918173 ↗
• MalfunctionApr 12, 2017Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THE SURGEON INSERTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -7.5 DIOPTER, AND THE LENS WENT INTO THE PATIENTS EYE UPSIDE DOWN. THE LENS WAS REMOVED WITHIN THE SAME SURGERY WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6488047 ↗

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-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. 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.
• 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.