EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.5) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841542119191), received between Oct 21, 2022 and Nov 21, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

7 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.

Recalls naming this device

1. Sep 29, 2023Class IIOpen, Classified

   Their is a potential that intraocular implant devices may not meet specifications.

   Z-0465-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED CLOUDINESS". IN A SEPARATE VISIT THE LENS WAS EXPLANTED. REPORTEDLY, "PATIENT ELECTED TO NOT REPLACE". IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754236 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN IMPLANTABLE COLLAMER LENS (ICL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED A LENS POWER ISSUE. THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED TO DATE. THERE ARE MULTIPLE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 2 TOTAL REPORTS. BASED ON THE INFORMATION PROVIDED, THE RISK ASSESSMENT FOR OUR PRODUCT, AND OUR EXPERIENCE, WE HAVE DETERMINED THE CAUSE OR CONTRIBUTION TO THE REPORTED ISSUE IS NOT INDICATIVE OF A MANUFACTURING RELATED ISSUE OR PRODUCT DEFICIENCY. ADDITIONAL INFORMATION WAS REQUESTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS FILE WILL BE RE-OPENED IF ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697723 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED AN IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD). THE SURGEON REPORTS THE PATIENT HAS ANTERIOR CHAMBER INFLAMMATION WITH SYMPTOMS OF MILD BLURRED VISION AND EYE REDNESS 1 MONTH AGO THAT WAS RESOLVED WITH SHORT COURSE OF PREDNISOLONE FOR 1 WEEK. IT WAS LATER REPORTED THE PATIENT HAD SIGNIFICANT INFLAMMATION IN THE RIGHT EYE BUT HER VISION IS STILL VERY GOOD 20/20 AND IOP IS 12MMHG. SURGEON NOTES THEY STARTED PREDNISOLONE THEN QID. LENS REMAINS IMPLANTED.

  Patient problems: Blurred Vision; Endophthalmitis; Inflammation; Red Eye(s)

  MAUDE report 17980259 ↗
• InjurySep 21, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. POST-OP THERE WAS 1+ PIGMENT IN ANTERIOR CHAMBER, IRIS WAS RESOLVING. THE PROBLEM WAS RESOLVED. THE LENS REMAINED IMPLANTED.

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

  MAUDE report 17792198 ↗
• MalfunctionJun 26, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -10.50 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. THE PATIENT COMPLAINED OF VITREOUS FLOATERS POST-OP AND THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Vitreous Floaters

  MAUDE report 17200362 ↗
• InjuryApr 12, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6 -10.50 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO LENS BEING INVERTED UPON IMPLANTATION, BACK UP LENS WAS USED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727884 ↗
• InjuryOct 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -10.5 DIOPTER WAS FLIPPED UPON INSERTION. THE LENS WAS REMOVED AND WAS REPLACED WITH THE BACKUP LENS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651814 ↗

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-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.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.