Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103497)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542103497), received between Sep 13, 2017 and Jan 4, 2019 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.7MM, MICL13.7, -6.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE ON (B)(6) 2018. ELEVATED IOP (INTRAOCULAR PRESSURE) WITHOUT PUPIL BLOCK AND ANGLE CLOSURE WAS OBSERVED, DATE ASSESSED: (B)(6) 2018. LENS REMAINS IMPLANTED, SURGEON HAD PLANNED TO EXCHANGE THE LENS ON (B)(6) 2018 FOR A SHORTER LENGTH LENS BUT THE SURGERY WAS POSTPONED BY THE PATIENT AND HAS NOT RESCHEDULED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 8219260 ↗
• InjuryNov 1, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE "SUREGON" ATTEMPTED TO IMPLANT A 13.7MM, MICL13.7, -6.5 DIOPTER INTO THE PATIENTS RIGHT EYE (OD) AND IT DID NOT FIT (TOO LARGE) SO HE EXPLANTED THE LENS AND IMPLANTED A SHORTER LENGTH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8030339 ↗
• MalfunctionSep 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER STATED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -6.5 DIOPTER, WAS TORN DURING LOADING, AS THE LENS WAS BEING FORWARDED. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6863590 ↗

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