EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542119382), received between Aug 24, 2022 and Mar 12, 2024 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 reports).

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-0466-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2. -8.5 DIOPTER, IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. MONOCULAR DIPLOPIA, DISCOMFORT, AND FLUCTUATING VISION WAS OBSERVED. PAITIENT PERSCRIBED CYCLOGYL 1% BID. LENS REMAINS IMPLANTED. PROBLEM NOT RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dry Eye(s)

  MAUDE report 18886366 ↗
• InjuryFeb 22, 2024Off-Label Use; Optical Problem; Off-Label Use; Optical Problem

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -8.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2024.THE LENS WAS REMOVED DUE TO GLARE AND HALOS. THE PROBLEM WAS RESOLVED. REPORTEDLY, "CLEAR/QUIET." THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18764165 ↗
• InjuryFeb 22, 2024Off-Label Use; Optical Problem; Off-Label Use; Optical Problem

  THE REPORTER INDICATED THAT 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -8.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2024. ON (B)(6) 2024, THE LENS WAS REMOVED DUE TO GLARE AND HALOS. THE PROBLEM WAS RESOLVED. REPORTEDLY, "CLEAR/QUIET." THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18764164 ↗
• InjuryFeb 2, 2024Optical Problem; Optical Problem

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -8.5 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2023. THE PATIENT EXPERIENCED GLARE/HALOES. ON (B)(6) 2024 THE LENS WAS EXPLANTED.

  Patient problems: Halo

  MAUDE report 18636809 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  NARROW ANTERIOR CHAMBER, ELEVATED INTRAOCULAR PRESSURE WITH PIGMENT DISPERSION AFTER ICL IMPLANTATION WAS REPORTED. LENS REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased

  MAUDE report 18341285 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 13.2MM VICM5_13.2 OF -8.50 DIOPTER IMPLANTABLE COLLAMER LENS HAD TO BE REMOVED AFTER IMPLANT BECAUSE THE CENTER HAD A HOLE IN IT. THE SURGEON STATED " DURING ROUTINE CASE, THE DEFECT IN THE CENTER HOLE OF THE LENS WAS NOTED AFTER BEING INSERTED IN THE EYE". THERE WAS NO INJURY TO THE PATIENT, A BACKUP LENS WAS IMPLANTED. IN THE REPORTERS OPINION THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300509 ↗
• InjuryJul 10, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2023. THE LENS WAS REMOVED LATER THAT SAME DAY DUE TO EXCESSIVE VAULTING. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. POST-OP THERE WAS GOOD POST-OPERATIVE APPEARANCE AND THE VAULT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292421 ↗
• MalfunctionJun 5, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2 VICM513.2 IMPLANTABLE COLLAMER LENS WITH A -8.5 DIOPTER WAS CRIMPED IN THE INJECTOR. THERE WAS NO PATIENT CONTACT, AND BACK UP LENS WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056777 ↗
• MalfunctionMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A VOLUNTARY MEDICAL DEVICE REPORT FROM FDA- MDR REPORT # MW5116464 ON 13-APR-2023. THE PATIENT REPORTED ON (B)(6) 2023, A "SERIOUS INJURY" EVENT REPORT WITH OUTCOMES OF "DISABILITY OR PERMANENT DAMAGE". THE PATIENT STATED "HAD STAAR MEDICAL'S IMPLANTABLE COLLAMER LENS, EVO ICL IMPLANTED INTO BOTH RIGHT AND LEFT EYE. NOTICED NEXT DAY A LOSS OF PERIPHERAL VISION. RETURNED TO DOCTOR, WAS TOLD TO WAIT A WEEK. RETURNED TO HAVE RETINA CHECKED, RETINA WAS OKAY". PATIENT STATES THAT ISSUE IS STILL PRESENT AND THAT THIS SIDE EFFECT WAS NOT LISTED AS A POSSIBLE SIDE EFFECT. PATIENT IS UNSATISFIED WITH POST-OP OUTCOME. PER THE SAME REPORT HEALTH EFFECT-CLINICAL AND MEDICAL DEVICE PROBLEM CODES: FAILURE OF IMPLANT, LOSS OF VISION AND PRODUCT QUALITY PROBLEM WERE REPORTED. ON (B)(6) 2023 THE PATIENT WAS ABLE TO PROVIDE US WITH ONE ICL SERIAL NUMBER, NAME OF THE IMPLANTING SURGEON, AND DATE OF IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM SURGEON, BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

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

  MAUDE report 16925028 ↗
• InjuryNov 23, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -08.50 DIOPTER, INTO THE PATIENTS LEFT EYE (OS) ON (B)(6) 2022. THE LENS WAS REPORTED AS HAVING A HIGH VAULT AND REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15856845 ↗
• InjuryAug 24, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT A 13.2MM VICM5 13.2 IMPLANTABLE COLLAMER LENS OF -8.50 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2022. ON (B)(6) 2022 THE LENS WAS REMOVED DUE TO A HIGH VAULT. A REPLACEMENT LENS WAS IMPLANTED OF UNKNOWN MODEL AND SIZE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: Intraocular Pressure Increased; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285150 ↗

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