EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0) (REF VICM5 13.2)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841542119436), received between Jan 4, 2023 and Jan 23, 2024 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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.

• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM, VICM5_13.2, -11.00 DIOPTER, IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENTS LEFT EYE (OS). THE PATIENT EXPERIENCED NARROW ANTERIOR CHAMBER, ELEVATED IOP WITH PIGMENT DISPERSION. IT WAS REPORTED THAT ON (B)(6) 2023 THE LENS WAS EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED 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; Intraocular Pressure Increased

  MAUDE report 18561095 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 13.2MM VICM5 13.2 IMPLANTABLE COLLAMER LENS OF -11.00 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. REBOUND POST-OP INFLAMMATION WAS REPORTED. PRE-MOXIBROM WAS RESTARTED AND THIS RESOLVED THE PROBLEM. THE LENS REMAINS IMPLANTED.

  Patient problems: Inflammation

  MAUDE report 18278965 ↗
• MalfunctionOct 17, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -11.00 DIOPTER WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. MILD SHALLOWING OF THE ACD WAS REPORTED, HOWEVER IT WAS ALSO REPORTED THAT MEDICAL OR SURGICAL INTERVENTION IS NOT NECESSARY. "LENS SIZE A BIT OFF" WAS REPORTED FOR CAUSE OF EVENT. THE REPORTER STATED THAT THE PATIENTS CURRENT CONDITION IS GOOD.

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

  MAUDE report 17954491 ↗
• InjuryOct 13, 2023Unintended Movement; Unintended Movement

  THE REPORTER INDICATED THAT A 13.2 VICM5 13.2 IMPLANTABLE COLLAMER LENS OF -11.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S EYE ON AN UNKNOWN DATE. ON AN UNKNOWN DATE THE LENS WAS IMPLANTED AND REMOVED DUE TO THE LENS FLIPPED IN THE EYE. A BACKUP LENS WAS IMPLANTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. 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 17936542 ↗
• InjuryOct 3, 2023Off-Label Use; Patient-Device Incompatibility; No Apparent Adverse Event; Off-Label Use; Patient-Device Incompatibility; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM513.2 IMPLANTABLE COLLAMER LENS OF A -11.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD). REPORTEDLY, "HYPEROPIC SURPRISE ON A PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17864496 ↗
• MalfunctionSep 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS OF -11.00 DIOPTER WAS STUCK IN CARTRIDGE OR INJECTION SYSTEM. THERE WAS PATIENT CONTACT WITH NO PATIENT INJURY. A REPLACEMENT LENS WAS IMPLANTED WITHIN THE SAME SURGERY AND THE PROBLEM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814861 ↗
• InjurySep 1, 2023Misfocusing; Inadequacy of Device Shape and/or Size; Misfocusing; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THE SURGEON IMPLANTED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -11.00 DIOPTER, INTO THE PATIENTS RIGHT EYE (OD) ON (B)(6) 2023. THE LENS WAS REMOVED ON (B)(6) 2023, DUE TO EXCESSIVE VAULTING, PUPIL BLOCK WITH ELEVATED INTRAOCULAR PRESSURE (IOP) AND BLURRED VISION. THE LENS WAS REPLACED WITH A SHORTER LENS AND THE PROBLEM WAS RESOLVED. POST-OP, THERE WAS 1+ PIGMENT ANTERIOR CHAMBER, THE IRIS WAS RESOLVING. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Pupillary Block

  MAUDE report 17672736 ↗
• MalfunctionJul 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THE SURGEON INSERTED AND REMOVED A 13.2MM VICM5_13.2 IMPLANTABLE COLLAMER LENS, -11.00 DIOPTER, DURING THE SAME SURGERY DUE TO LENS TEAR/BREAK DURING INJECTION/DELIVERY INTO THE PATIENTS LEFT EYE (OS). THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH ANOTHER SAME MODEL/LENGTH LENS AND THE PROBLEM WAS RESOLVED. THE EYE IS DOING WELL. THE CAUSE OF THE EVENT WAS DUE TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253004 ↗
• InjuryApr 28, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED, THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2023. "OVERSIZED" LENS 1 DAY POST-OP WAS REPORTED. LENS REMAINS IMPLANTED. 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 16837663 ↗
• InjuryApr 28, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT AN IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S EYE ON (B)(6) 2023. "OVERSIZED" LENS 1 DAY POST-OP WAS REPORTED. LENS REMAINS IMPLANTED. 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 16837304 ↗
• InjuryJan 4, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 13.2MM VICM5_13.2; -11.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS). THE LENS WAS EXPLANTED AND REPLACED WITH A SHORTER LENGTH LENS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096053 ↗

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-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. 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.