IC-8 Apthera IOL +19.0 DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813359020915), received between Feb 27, 2024 and Oct 17, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE IOL TRAILING HAPTIC WAS ALLEGEDLY STUCK IN THE INJECTOR. THE FOLLOWING DAY, THE SURGEON OBSERVED THAT THE IOL WAS DECENTERED. APPROXIMATELY, 2 WEEKS LATER, AN IOL EXCHANGE WAS PERFORMED, AND IT WAS NOTED THAT THERE WAS A BROKEN HAPTIC ON THE INITIAL IOL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE BROKEN HAPTIC. PATIENT OUTCOME IS GOOD.

  Patient problems: Visual Impairment

  MAUDE report 23323417 ↗
• InjuryNov 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 EYE, THE PATIENT WAS DISSATISFIED WITH THE QUALITY OF VISION, COMPLAINING EVERYTHING WAS TRIPLED, AND EXPERIENCING VISUALLY INDUCED NAUSEA. TWO WEEKS AFTER INITIAL IMPLANTATION, THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL IOL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Diplopia/Double Vision; Nausea

  MAUDE report 20789317 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED SYMPTOMS OF DECREASED QUALITY OF VISION, DIMNESS, AND SEEING A STREAK OF LIGHT FROM POINT SOURCES OF LIGHT. THE USE OF A RIGID GAS PERMEABLE LENS OVER REFRACTION DID NOT ALLEVIATE ANY OF THESE SYMPTOMS, AND SYMPTOMS PERSISTED WITH BCVA 20/20. APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF EVENT IS DIMNESS FROM EFFECT OF SMALL APERTURE OPTICS AND POSITIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

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

  MAUDE report 18788893 ↗