Visian ICL (Implantable Collamer Lens) MICL 13.2 (UDI 00841542103213)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841542103213), received between May 19, 2016 and May 13, 2021 — classified as 6 injuries, 2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2021Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATES A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS -6.0 DIOPTER WAS "VOLD TO FLAT, REMOVE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823295 ↗
• MalfunctionApr 12, 2021Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.0 TORE DURING LOADING. THERE WAS PATIENT CONTACT WITH THE LENS. REPORTEDLY THE LENS TURNED UPSIDE DOWN AND WHEN THE DOCTOR TRIED TO FIX IT, IT TORE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654122 ↗
• InjuryJan 27, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -6.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2020. EXCESSIVE VAULT, PUPIL BLOCK, ANGLE CLOSURE WITH ELEVATED IOP (43MMHG), GLARE/HALOES AND BLURRED VISION WAS OBSERVED. ADDITIONAL SURGICAL INTERVENTION (PI) WAS PERFORMED. IT WAS REPORTED THAT THE PROBLEM RESOLVED, LAST VISIT DATE (B)(6) 2020 (BCVA:20/20, UCVA:20/25-, VAULT:1.0 CT, IOP:14MMHG). THE REPORTER STATED "HE DEVELOPED A STEROID RESPONSE WITH CORNEAL EDEMA (B)(6) 2020 AND WAS SWITCHED TO LOTEMAX FROM PREDNISOLONE ACETATE 1%. HAS SINCE BEEN TAPERED OFF ALL STEROIDS AND IOP LOWERING MEDICATIONS SUCCESSFULLY." IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT MAY HAVE BEEN RETAINED OVD BEHIND THE IOL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Halo; Intraocular Pressure Increased; Pupillary Block; Visual Disturbances

  MAUDE report 11234650 ↗
• InjuryNov 7, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.0 DIOPTER, IN THE PATIENTS LEFT EYE (OS) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO PROBLEMS WITH VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS. 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 9293575 ↗
• InjuryFeb 14, 2019Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE SURGEON REPORTED THAT HE ATTEMPTED TO IMPLANT A 13.2MM, MICL13.2, -6.0 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S EYE BUT IT WOULD NOT UNFOLD. " I NEVER COMPLETED THE INSERTION INTO THE EYE BECAUSE THE LENS WOULD NOT UNFOLD ABOUT 65% OUT OF THE INJECTOR AND I FELT IT NOT PRUDENT TO PROCEED GIVEN THE 3 ATTEMPTS TO ALLOW IT TO UNFOLD. THE LENS WAS NEVER FULLY IMPLANTED, THE LENS WAS ALLOWED TO COME OUT OF THE INJECTOR ABOUT 60-70% AND ALLOWED TO UNFOLD BUT IT NEVER DID. I USED MANEUVERS SUCH AS "JIGGLING" THE INJECTOR. I REMOVED THE INJECTOR EACH TIME, RELOADED, AND INSERTED 2 ADDITIONAL TIMES. NO LASTING INJURY TO THE PATIENT. JUST MORE CORNEAL EDEMA THAN USUAL, BUT IT RESOLVED AS EXPECTED. CAUSE OF CORNEAL EDEMA IS UNCLEAR, LIKELY SURGERY BUT GIVEN THE FACT THAT THE PRODUCT MADE THE SURGERY MORE COMPLICATED THAN NECESSARY, COULD BE PRODUCT AS WELL, BUT NOT DIRECTLY. NO, CORNEAL EDEMA DID NOT REQUIRE TREATMENT BEYOND WHAT IS STANDARD AFTER OCULAR SURGERY."

  Patient problems: Corneal Edema

  MAUDE report 8339700 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.0 DIOPTER, LENS WAS RECEIVED RETURNED WITH A NOTE, "EXPLANTED LENS" ON IT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 7870378 ↗
• MalfunctionAug 14, 2018Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM, MICL13.2, -6.0 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED IN THE PATIENTS LEFT EYE (OS) UPSIDE DOWN . THE LENS WAS REMOVED AND THE BACK UP LENS WAS IMPLANTED WITHIN THE SAME SURGERY. THERE WAS NO PATIENT INJURY, CAUSE OF EVENT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783188 ↗
• InjuryMay 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 INDICATED THE SURGEON IMPLANTED A 13.2MM MICL13.2 IMPLANTABLE COLLAMER LENS, -6.0 DIOPTER, IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE LENS WAS EXPLANTED ON (B)(6) 2016 DUE TO EXCESSIVE VAULTING, ANGLE CLOSURE, PUPILLARY BLOCK AND ELEVATED INTRAOCULAR PRESSURE. ADDITIONAL LASER PERIPHERAL IRIDOTOMIES WERE PERFORMED. THE REPORTER INDICATED THEY FELT THERE WAS POSSIBLE AQUEOUS MISDIRECTION. THE LENS WAS NOT EXCHANGED FOR ANOTHER LENS. THE PATIENT'S POST-OP BEST-CORRECTED VISUAL ACUITY WAS 20/20.

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

  MAUDE report 5668563 ↗

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-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.
• 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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.