IC-8 Apthera IOL +22.0 DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813359020977), received between May 19, 2023 and Dec 24, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2024Material Opacification; Material Opacification

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT COMPLAINED OF POOR VISUAL QUALITY AND STATED THEY WERE INCAPACITATED IN DIM LIGHTING OR DUSK CONDITIONS. UPON EXAMINATION, THE SURGEON OBSERVED AN AREA ON THE ANTERIOR SURFACE OF THE LENS WITHIN THE CENTRAL APERTURE NOTED AS A SCRATCH/OPACITY/GLISTENING. SIX WEEKS AFTER IMPLANTATION, THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL IOL DUE TO UNRESOLVED INTOLERABLE VISUAL DISTURBANCE AND SECONDARY NYCTALOPIA. IN THE SURGEON'S OPINION THE MOST LIKELY CAUSE OF THE EVENT WAS THE PATIENT BEING UNABLE TO ADAPT TO DIM LIGHT/LIGHT BLOCK FROM PINHOLE OPTICS AS WELL AS POSSIBLE SECONDARY CAUSE FROM SCRATCHING/OPACITY RIGHT IN THE CENTER OF THE LENS. PATIENT HAS A GOOD PROGNOSIS OF RETURNING TO 20/20 BSCVA.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21012410 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL, DUE TO DIMNESS IN VISION. THE PATIENT HAS RECOVERED.

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

  MAUDE report 20277983 ↗
• InjuryMay 19, 2023Break; Break

  IT WAS REPORTED THAT DURING THE PLACEMENT OF AN INTRAOCULAR LENS, THE LENS TORE AT THE HAPTIC JUNCTION. AFTER IMPLANTATION INTO THE EYE, THE LENS WAS REMOVED AND A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS ATTEMPTED. THE BACK UP LENS IMPLANTATION WAS NOT SUCCESSFUL AND THE IRIS WAS TORN DURING THE REMOVAL OF THE BACK UP LENS. THE PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED OF THE REPORTER, BUT HAS NOT BEEN PROVIDED. LENS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970035 ↗
• InjuryMay 19, 2023Break; Break

  IT WAS REPORTED THAT DURING THE PLACEMENT OF AN INTRAOCULAR LENS, THE LENS TORE AT THE HAPTIC JUNCTION. AFTER IMPLANTATION INTO THE EYE, THE LENS WAS REMOVED AND A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS ATTEMPTED. THE BACK UP LENS IMPLANTATION WAS NOT SUCCESSFUL AND THE IRIS WAS TORN DURING THE REMOVAL OF THE BACK UP LENS. THE PATIENT WAS LEFT APHAKIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED OF THE REPORTER, BUT HAS NOT BEEN PROVIDED. LENS 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16967013 ↗