IC-8 Apthera IOL +22.5 DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813359020984), received between Mar 8, 2024 and Dec 22, 2025 — classified as 4 injuries.

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

• InjuryDec 22, 2025Material Discolored; Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Material Discolored; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  T WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENTS EYE DUE TO BLURRED VISION WITH A PURPLE HUE. CENTRAL POSTERIOR STREAKS WERE ALSO VISIBLE ON THE LENS. A SECOND IOL OF A DIFFERENT LENS MODEL AND POWER WERE IMPLANTED SUCCESSFULLY. THE SURGEON INDICATED THE CAUSE OF THE EVENT WAS POSSIBLY THE DELIVERY DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 23863259 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING A DIFFERENT MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED IN THE PATIENT¿S FELLOW EYE ON THE SAME DATE. SINCE THE EXCHANGE PATIENT OUTCOME IS REPORTEDLY GOOD.

  Patient problems: Insufficient Information; Visual Disturbances

  MAUDE report 21583536 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT COMPLAINED OF HALOS AND GHOSTING IMAGES. APPROXIMATELY ONE AND A HALF MONTHS AFTER ONSET OF SYMPTOMS, YAG WAS PERFORMED FOR BLURRED VISION, GLARE AND DYSPHOTOPSIA, BUT SYMPTOMS DID NOT IMPROVE. APPROXIMATELY FIVE MONTHS AFTER IMPLANTATION, THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL IOL, WITH A DIFFERENCE OF 3.5 DIOPTERS. AS OF THE 1-DAY POST-EXCHANGE EXAM, PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 20746360 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE PATIENT COMPLAINED OF POOR VISUAL ACUITY AND HEADACHES. APPROXIMATELY 3 MONTHS POST-IMPLANTATION OF THE INITIAL IOL, THE LENS WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 18870935 ↗