Aaris Acrylic Intraocular lens(IOL) EC-3 PAL (UDI 00884872025305)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884872025305), received between Mar 14, 2017 and Apr 9, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Scratched Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER IMPLANTATION IT WAS NOTED THAT THERE WAS A SCRATCH ON THE OPTIC AREA; THUS, THE LENS WAS REMOVED. THERE WAS NO DAMAGE NOTED DURING THE LOADING OR PREPARATION OF THE LENS. ANOTHER LENS WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7409572 ↗
• InjurySep 22, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER IMPLANTATION OF AN EC-3 PAL LENS A SCRATCH WAS NOTED ON THE OPTIC AREA; THUS, THE LENS WAS EXPLANTED. ANOTHER LENS WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6888777 ↗
• InjuryMar 14, 2017Improper or Incorrect Procedure or Method; Optical Problem; Improper or Incorrect Procedure or Method; Optical Problem

  IT WAS REPORTED THAT AN EC-3 PAL LENS WAS LOADED, PREPPED AND IMPLANTED. YAMANE PROCEDURE WAS USED TO IMPLANT THE LENS; HOWEVER, IT WAS NOTED THAT THE LENS HAPTICS KEPT TORQUEING AND NOT ALLOWING THE LENS TO BE PROPERLY POSITIONED IN THE EYE. AFTER MULTIPLE ATTEMPTS WITH MANIPULATION, IT WAS NOTED THAT ONE OF THE HAPTICS HAD BEEN TORN OFF. THE LENS WAS REMOVED AND ANOTHER AAREN LENS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SLIGHT DELAY IN THE PROCEDURE WAS REPORTED; HOWEVER, THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT AS THE PATIENT IS DOING WELL AND THERE WAS NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6403608 ↗