Visian ICL (Implantable Collamer Lens) MICL 13.7 (UDI 00841542103527)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841542103527), received between May 6, 2016 and Nov 21, 2017 — classified as 3 injuries.

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.

• InjuryNov 21, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED THAT THE SURGEON IMPLANTED A MICL13.7, -8.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S EYE ON (B)(6) 2017. IT WAS NOTICED THAT THE LENS WAS TOO BIG. IT IS UNSURE IF THE LENS IS GOING TO BE EXCHANGED FOR A SHORTER LENS. THERE IS NO PATIENT INJURY. ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7050893 ↗
• InjuryJul 19, 2016Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.7MM MICL13.7 IMPLANTABLE COLLAMER LENS, -8.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO AN EXCESSIVE VAULT. THE PATIENT EXPERIENCED AN ELEVATED IOP, PUPILLARY BLOCK, POST-OP PAIN, AND CLOUDY VISUAL ACUITY (VA). THE REPORTER INDICATED THE EVENT WAS PRODUCT-RELATED AND THE DEVICE CONTRIBUTED TO THE EVENT. THE LENS WAS EXCHANGED FOR A SHORTER LENS. THE REPORTER STATED THE CAUSE OF THE EVENT WAS WHITE-TO-WHITE MISMEASUREMENT. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY (BCVA) WAS 20/25.

  Patient problems: Intraocular Pressure Increased; No Code Available; Pain; Pupillary Block

  MAUDE report 5804108 ↗
• InjuryMay 6, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED - THE CUSTOMER REPORTED THE LENS WAS EXPLANTED.

  Patient problems: Corneal Edema; Endophthalmitis; Hypopyon; Intraocular Pressure Increased; No Code Available; Pupillary Block; Vitrectomy

  MAUDE report 5639098 ↗

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