SofPort® IOL LI61AO (REF LI61AOR1500)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770474216), received between Dec 23, 2022 and Feb 16, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, THE PATIENT REPORTED HALOS, STARBURSTS AND BLURRY VISION. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16389798 ↗
• InjuryDec 23, 2022Device Dislodged or Dislocated; Material Integrity Problem; Device Dislodged or Dislocated; Material Integrity Problem

  REPORTEDLY, AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE IT WAS DISCOVERED THAT IOL HAPTICS WERE BENT. THE SURGEON ATTEMPTED TO STRAIGHTEN THE HAPTICS AND DURING THE PROCESS THE IOL FLIPPED OVER AND SCRATCHED THE CORNEA. ON POST-OP VISIT IT WAS DISCOVERED THAT LENS HAD SHIFTED CAUSING PAIN AND VISUAL PROBLEMS FOR THE PATIENT. THE LENS WAS EXPLANTED 3 DAYS POST IMPLANT DUE TO LENS DISLOCATION AND EXTRUDED LENS IN THE ANTERIOR CHAMBER. A VITRECTOMY WAS PERFORMED, AND THE LENS WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER.

  Patient problems: Corneal Scar; Eye Pain; Visual Impairment

  MAUDE report 16042553 ↗