IC-8 Apthera IOL +23.0 DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00813359020991), received between Jun 28, 2024 and Sep 10, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT DEVELOPED CAPSULAR CONTRACTION. APPROXIMATELY ONE MONTH AFTER IMPLANTATION OF THE IOL, THE PATIENT COMPLAINED OF A BROWN OR HAZY MIST, STATING IT WAS LIKE LOOKING THROUGH A CURTAIN. THE PATIENT REPORTED NOTICING A DECREASE IN VISION, BUT VISUAL ACUITY DID NOT DECREASE. THE SURGEON OBSERVED THE LENS TO BE DE-CENTERED NASALLY. APPROXIMATELY TWO WEEKS LATER, THE LENS WAS REPOSITIONED, AND A CAPSULAR TENSION RING WAS IMPLANTED. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS UNKNOWN AND IS CONSIDERING EXCHANGING THE IOL DUE TO UNRESOLVED HAZE. THE PATIENT REMAINS UNDER THE SURGEON'S CARE AND IS SCHEDULED TO BE SEEN AGAIN IN THE BEGINNING OF 2026.

  Patient problems: Capsular Contracture; Visual Disturbances

  MAUDE report 23014495 ↗
• InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED WITH THE SURGEON INDICATING NO ISSUES WITH THE IOL. LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER THE ORIGINAL IMPLANT DUE TO VISION ISSUES SUCH AS NOT SEEING WELL, VERY DIM AND LOOKING THROUGH A KEYHOLE.

  Patient problems: Insufficient Information

  MAUDE report 22819197 ↗
• InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED WITH THE SURGEON INDICATING NO ISSUES WITH THE IOL. LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER THE ORIGINAL IMPLANT DUE TO VISION ISSUES SUCH AS NOT SEEING WELL, VERY DIM AND LOOKING THROUGH A KEYHOLE.

  Patient problems: Insufficient Information

  MAUDE report 22819092 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE, THE PATIENT EXPERIENCED HALOS. APPROXIMATELY 2 MONTHS AFTER IMPLANTATION OF THE IOL, IT WAS EXCHANGED WITH A DIFFERENT MODEL LENS DUE TO UNRESOLVED HALOS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF EVENT IS HALOS INDUCED BY IOL AND INCREASED PUPIL SIZE AT BASELINE, WITH DILATED PUPIL SIZE MEASUREMENT OVER 7MM. THE PATIENT HAS RECOVERED.

  Patient problems: Halo

  MAUDE report 20063180 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE IOL WAS REMOVED APPROXIMATELY SIX MONTHS POST IMPLANT INTO THE LEFT EYE AND REPLACED WITH A DIFFERENT MODEL IOL. ALLEGEDLY, THE PATIENT ONLY HAD CLEAR VISION WHEN OUTSIDE IN NATURAL LIGHT. THE PATIENT¿S CONDITION IS REPORTED AS STABLE.

  Patient problems: Visual Impairment

  MAUDE report 19633196 ↗