SofPort® IOL LI61AO (REF LI61AOR1850)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10757770474285), received between Feb 15, 2023 and Apr 22, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 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.

• InjuryApr 22, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL), THE HAPTIC BECAME STUCK IN THE INJECTOR AND WAS AMPUTATED. THE LENS WAS REMOVED AND THE INCISION WAS ENLARGED. A REPLACEMENT IOL OF THE SAME MODEL AND POWER WAS PLACED, AND A SUTURE WAS REQUIRED. THE PATIENT IS EXPECTED TO EXPERIENCE A PROLONGED RECOVERY PERIOD; HOWEVER, THE OVERALL PROGNOSIS IS EXCELLENT.

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

  MAUDE report 24955880 ↗
• InjuryNov 18, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE DAYS AFTER THE IMPLANTATION OF AN INTRALOCULAR LENS(IOL), INTO THE RIGHT EYE (OD), A SUCCESSFUL LENS EXCHANGE USING A DIFFERENT MODEL IOL WAS COMPLETED DUE TO DISLOCATION OF THE IOL. A VITRECTOMY WAS PERFORMED. ADDITIONAL INFORMATION REQUESTED, BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 20717523 ↗
• InjurySep 7, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE POSTERIOR CAPSULE RUPTURED CAUSING THE LENS TO BE UNSTABLE. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUTURE WAS PLACED AS STANDARD PROTOCOL. APPROXIMATELY TEN DAYS AFTER EXPLANT, A VITRECTOMY WAS PERFORMED AND A LENS OF THE SAME MODEL, SAME DIOPTER WAS IMPLANTED. PATIENT OUTCOME IS GOOD.

  Patient problems: Capsular Bag Tear

  MAUDE report 17702006 ↗
• InjuryApr 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE LENS WAS REMOVED AND REPLACED INTRAOPERATIVELY DUE TO A BENT HAPTIC. THE INCISION WAS ENLARGED. NO SUTURES WERE REQUIRED AND THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724560 ↗
• InjuryFeb 15, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE EYE, IT WAS NOTICED THE HAPTIC WAS DAMAGED, ALLEGEDLY BY THE SLIDE MECHANISM OF THE INJECTOR. THE INCISION WAS ENLARGED AND A SUCCESSFUL INTRAOPERATIVE LENS REPLACEMENT USING THE SAME MODEL AND DIOPTER IOL WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380622 ↗