EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.0) (REF VICM5 12.6)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841542119160), received between Oct 12, 2022 and May 20, 2024 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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-0465-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

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.

• MalfunctionMay 20, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT THE SURGEON NOTED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS OF DIOPTER -9.00 TORE/BROKE DURING LOADING ON (B)(6) 2024. THE DAMAGE WAS NOTED "AFTER OPENING VIAL". THE LENS WAS NOT IMPLANTED. . REPORTEDLY "DID NOT MAKE PATIENT CONTACT". ON THE SAME DAY A BACK UP LENS OF THE SAME PARAMETERS WAS IMPLANTED INTO THE PATIENTS RIGHT EYE (OD) AND THE PROBLEM WAS RESOLVED. STATUS OF THE EYE: "DOING VERY WELL". THE REPORTER INDICATED THE CAUSE OF THE EVENT WAS USER ERROR AND THE DEVICE DID NOT FAIL TO PERFORM AS INTENDED. CAUSE DETAILS PROVIDED: "PIECE OF LENS TORE OFF WHILE SEATING ICL INTO THE TIP OF THE LENS CARTRIDGE USING THE ICL LOADING FORCEPS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353038 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -9.00 DIOPTER WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON AN UNKNOWN DATE. REPORTEDLY THE DOCTOR NOTICED A SMUDGE ON THE LENS. THE LENS WAS REMOVED AND REPLACED WITH THE BACKUP LENS, IT IS UNCLEAR IF THIS OCCURRED DURING THE SAME SURGERY. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177983 ↗
• MalfunctionApr 9, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT A 12.6MM VICM5 12.6 IMPLANTABLE COLLAMER LENS OF -9.00 DIOPTER GOT STUCK IN THE INJECTOR WHEN THE DOCTOR TRIED TO IMPLANT THE LENS ON (B)(6) 2024. NO PATIENT INJURY WAS REPORTED AND THE DOCTOR USED THE BACKUP LENS. NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076105 ↗
• InjuryJan 10, 2024Inadequacy 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 INDICATED THAT 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A -9.0 DIOPTER WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2023. ON (B)(6) 2024, THE LENS WAS REMOVED AND REPLACED FOR A LONGER LENGTH LENS AND THE PROBLEM WAS RESOLVED. CAUSE OF THE EVENT IS OTHER. REPORTEDLY, "NEEDED A LONGER LENGTH" AND "THE DIAMETER OF THE LENS IS OFF AND THE LENS IS 'FLOATING.'"

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

  MAUDE report 18486437 ↗
• MalfunctionMay 9, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED THAT ON (B)(6) 2023 A VICM5_12.6, -09.0 DIOPTER, IMPLANTABLE COLLAMER LENS TORE DURING INJECTION INTO THE EYE. THERE WAS PATIENT CONTACT (LENS TOUCHED THE EYE) WITH NO PATIENT INJURY. THE LENS WAS REMOVED AND REPLACED WITH THE BACK UP LENS WITHIN THE SAME SURGERY, ON (B)(6) 2023. REPORTEDLY, PATIENT EYE IS "EXCELLENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894709 ↗
• InjuryMar 22, 2023Misfocusing; Improper or Incorrect Procedure or Method; Misfocusing; Improper or Incorrect Procedure or Method

  THE REPORTER INDICATED THAT A 12.6MM VICM512.6 IMPLANTABLE COLLAMER LENS OF A DIOPTER OF -9.0 WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2022. ON (B)(6) 2023, THE LENS WAS REMOVED AND REPLACED FOR A DIFFERENT MODEL DUE TO REFRACTIVE SURPRISE AND BLURRED VISON. CAUSE OF THE EVENT IS UNKNOWN. REPORTEDLY, "SURGICAL INCISION INDUCED MORE ASTIMATISM THAN EXPECTED," AND "REFRACTIVE MISS - PATIENT HAD 1.D OF ASTIGMASTISM AFTER SPHERICAL ICL PLACEMENT, DESPITE HAVING ONLY 0.5D PRE-OP SO I EXCHANGED THE SPHERICAL ICL FOR A TORIC." THE STATUS OF THE EYE IS REPORTED AS, "HEATHY."

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16595254 ↗
• InjuryDec 7, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE REPORTER INDICATED THAT THE SURGEON IMPLANTED A 12.6MM VICM5_12.6; -9.00 DIOPTER IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S RIGHT EYE (OD). IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO OVER SIZED VAULTING. 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 15936638 ↗
• InjuryOct 20, 2022Misfocusing; Off-Label Use; Misfocusing; Off-Label Use

  THE REPORTER INDICATED THAT A 12.6MM VICM5_12.6, -9.0 DIOPTER IMPLANTABLE COLLAMER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON 18-MAY-2022. IT WAS REPORTED THAT LIMBAL RELAXING INCISIONS (LRIS) WERE MADE TO REDUCE ASTIGMATISM BUT IT DID NOT REDUCE THE EXPECTED AMOUNT. ON (B)(6) 2022 THE LENS WAS EXCHANGED FOR A TORIC LENS TO ADDRESS THE ASTIGMATISM (HIGH CYLINDER POWER) AND THE PROBLEM RESOLVED. IN THE REPORTERS OPINION THE CAUSE OF THIS EVENT WAS USER ERROR, PRODUCT DID NOT FAIL TO PERFORM AS INTENDED.

  Patient problems: Blurred Vision

  MAUDE report 15640034 ↗
• MalfunctionOct 12, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTER INDICATED A 12.6MM VICM5_12.6 IMPLANTABLE COLLAMER LENS, -09.00 DIOPTER, TORE DURING LOADING AND THERE WAS NO PATIENT CONTACT. THE LENS TORE WHILE BEING PULLED THROUGH THE CARTRIDGE. THE BACKUP LENS WAS IMPLANTED AND THE PROBLEM WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591713 ↗

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-0467-2024 · Sep 29, 2023 · Open, Classified
  EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
• Z-0469-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
• Z-0464-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
• Z-0474-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
• Z-0468-2024 · Sep 29, 2023 · Open, Classified
  EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
• Z-0466-2024 · Sep 29, 2023 · Open, Classified
  EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.