Visian ICL (Implantable Collamer Lens) MICL 12.6 (UDI 00841542102940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841542102940), received between Sep 20, 2016 and Nov 11, 2022 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -06.00 DIOPTER, IN THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS REPORTED AS REFRACTIVE CHANGE OVERTIME AND REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15784668 ↗
• InjurySep 24, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A 12.6MM, MICL12.6, -6.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS REMOVED FROM THE PATIENTS RIGHT EYE (OD) AND REPLACED WITH A SHORTER LENGTH LENS DUE TO SIZING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530649 ↗
• MalfunctionApr 11, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 12.6MM. MICL12.6, -6.0 DIOPTER, IMPLANTABLE COLLAMER LENS IS TOO LARGE FOR THE PATIENT, INCREASED EYE PRESSURE. WILL BE REPLACING WITH A SHORTER LENGTH LENS. NO PATIENT INJURY. HOWEVER, THE PATIENT LATER STATED " IF THERE WAS SOMETHING WRONG THE IMPLANT WOULD HAVE BEEN REMOVED". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Inflammation; Intraocular Pressure Increased

  MAUDE report 8504763 ↗
• InjuryMar 27, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -6.0 DIOPTER, ON (B)(6) 2019. THE LENS WAS EXPLANTED THE SAME DAY DUE TO THE LENS WAS TOO LARGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8457871 ↗
• InjuryNov 16, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -6.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 AND EXCHANGED FOR A SHORTER LENS. THE LENS WAS DISCARDED. 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 7037331 ↗
• InjuryNov 16, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -6.0 DIOPTER, IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 AND EXCHANGED FOR A SHORTER LENS. THE LENS WAS DISCARDED. 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 7037201 ↗
• MalfunctionSep 18, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -6.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. EXCESSIVE VAULT WAS NOTICED. THE PATIENT IS FINE AND THERE IS NO PLAN FOR FUTURE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6872460 ↗
• InjurySep 18, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A MICL12.6, -6.0 DIOPTER, IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. ON (B)(6) 2017, THE LENS WAS EXPLANTED DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE, ELEVATED IOP, NARROWING OF THE ANGLE, BLURRY VISION, PAIN, PUPILLARY BLOCK, AND CORNEAL EDEMA. THE LENS WAS EXCHANGED FOR A SHORTER LENS AND VIGAMOX AND PREDNISOLONE WERE USED AS STANDARD POST OPERATIVE PROTOCOL. THE PROBLEMS WERE RESOLVED.

  Patient problems: Blurred Vision; Corneal Edema; Intraocular Pressure Increased; No Code Available; Pain; Pupillary Block

  MAUDE report 6872434 ↗
• InjuryNov 9, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER STATED THE SURGEON INSERTED A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -6.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS NOTED TO BE TOO BIG AND WAS REMOVED DURING THE SAME SURGERY WITH NO PATIENT INJURY OR COMPLICATIONS. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE REPORTER STATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6089900 ↗
• MalfunctionSep 20, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON ATTEMPTED TO LOAD A 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS, -6.0 DIOPTER, BUT THE "GRASPER" TORE THE LENS. THERE WAS NO PATIENT CONTACT OR INJURY. THE BACKUP LENS WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5965489 ↗

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-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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0465-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.