Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103404)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841542103404), received between Jun 29, 2016 and Mar 24, 2021 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM MICL13.2, -15.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2021. THE LENS WAS REMOVED AND THEN A NEW SHORTER LENGTH LENS DUE TO EXCESSIVE VAULT WAS IMPLANTED ON (B)(6) 2021. THIS RESOLVED THE PROBLEM. CAUSE OF THE EVENT IS REPORTED AS PATIENT-RELATED FACTOR,"LENS WAS TOO BIG".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563247 ↗
• InjuryAug 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED A 13.2MM MICL13.2,-15.5 DIOPTER, IMPLANTABLE COLLAMER LENS WAS REMOVED FROM THE PATIENTS LEFT EYE (OS) BECAUSE IT WAS TOO BIG. THE LENS WAS LATER EXCHANGED (DIFFERENT SURGERY) FOR A SMALLER LENS AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 7791779 ↗
• InjuryJun 14, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2 MM MICL13.2, -15.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(4) 2018. ON (B)(6) 2018 THE LENS WAS REMOVED AND EXCHANGED WITH A SHORTER LENGTH LENS DUE TO OBSERVATION OF EXCESSIVE VAULT, SIGNIFICANT REDUCTION OF IRIDO-CORNEAL ANGLES, PUPIL BLOCK AND ANGLE CLOSURE WITH ELEVATED IOP (INTRAOCULAR PRESSURE).ADDITIONAL SURGICAL INTERVENTION (YAG PI) WAS PERFORMED ON (B)(6) 2018. IT WAS REPORTED THAT AT PATIENTS LAST FOLLOW UP, VAULT AND IOP (INTRAOCULAR PRESSURE) WERE MUCH IMPROVED.

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

  MAUDE report 7602293 ↗
• MalfunctionFeb 8, 2018Positioning Failure; Positioning Failure

  THE REPORTER INDICATED THAT THE SURGEON INSERTED A MICL13.2, -15.5 DIOPTER, IMPLANTABLE COLLAMER LENS, AND THE LENS UNFOLDED UPSIDE DOWN. THE LENS WAS REMOVED DURING INITIAL SURGERY AND THE BACK UP LENS WAS USED. THERE WAS NO PATIENT INJURY. THE REPORTER STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7252889 ↗
• MalfunctionDec 12, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2 MM MICL 13.2 LENS, DIOPTER -15.5 WAS TO BE EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2017, POSSIBLY DUE TO AN OVER VAULT. ATTEMPTS TO OBTAIN ADDITIONAL OR UPDATED INFORMATION HAVE BEEN UNSUCCESSFUL.

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

  MAUDE report 7109939 ↗
• InjuryAug 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE REPORTER INDICATED THAT THE SURGEON WAS LOADING A MICL13.2, -15.5 DIOPTER, IMPLANTABLE COLLAMER LENS ON (B)(6) 2017. IT WAS NOTICED THAT THE LENS TORE WHILE LOADING. THE LENS WAS NOT IMPLANTED AND THERE WAS NO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818713 ↗
• InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -15.5 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2017 DUE TO THE PATIENT WAS UNHAPPY WITH THE LENS DUE TO PERSISTENT GLARE AND HALOS. THE LENS WAS EXPLANTED WITH NO PATIENT INJURY, NO INCISION ENLARGEMENT OR SUTURES. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE PATIENT HAS RETURNED TO WEARING CONTACT LENSES AND IS DOING WELL. THE REPORTER STATED THE EVENT WAS NOT PRODUCT RELATED, IT WAS A PATIENT ISSUE.

  Patient problems: Halo; No Code Available

  MAUDE report 6734732 ↗
• MalfunctionAug 26, 2016Torn Material; Torn Material

  THE REPORTER STATED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -15.5 DIOPTER, TORE WHILE BEING LOADED INTO THE INJECTOR. THERE WAS NO PATIENT CONTACT. THE REPORTER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5909201 ↗
• MalfunctionJun 29, 2016Torn Material; Torn Material

  THE REPORTER STATED THE SURGEON WAS ADVANCING A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -15.5 DIOPTER, FORWARD FROM THE CARTRIDGE WITH A FORCEP AND THE LENS TORE. THERE WAS NO PATIENT CONTACT AND THE BACKUP LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5758705 ↗

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-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.
• 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-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.