SENSAR IOL AAB00 (REF AAB0000260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474548787), received between Sep 2, 2025 and May 12, 2026 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMay 12, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT DURING THE NON-PRELOADED INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE IOL WAS ABOUT TO EXIT THE TIP OF THE CARTRIDGE, THE IOL BURST THROUGH THE TIP OF THE CARTRIDGE AND CAME OUT WITH ONE OF THE HAPTICS BROKEN. THE PHYSICIAN¿S IMPRESSION WAS THAT THERE WAS A PROBLEM WITH THE CARTRIDGE. ACCOUNT INDICATED THAT THE IOL WAS IN CONTACT WITH THE PATIENT'S EYE; HOWEVER, IT BECAME LODGED INSIDE THE CARTRIDGE. THE REPLACEMENT IOL WAS FROM A DIFFERENT MANUFACTURER WITH THE SAME DIOPTER. THERE WAS A 15 MINUTE DELAY IN PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156404 ↗
• InjurySep 2, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), A PERMANENT CREASE LINE WAS OBSERVED AT THE OPTIC CENTER. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE, WHICH REQUIRED AN ENLARGED INCISION, SUTURES, AND A VITRECTOMY. THE PROCEDURE WAS DELAYED, AND THE PATIENT REQUIRED MEDICAL ATTENTION AND MEDICATION. THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT. INSTRUCTIONS FOR USE WERE FOLLOWED. ADDITIONAL INFORMATION RECEIVED ON AUGUST 18 AND 19, 2025, CLARIFIED DETAILS REGARDING THE INTERVENTION MENTIONED IN THE COMPLAINT FORM SUBMITTED BY THE HOSPITAL. THE UNPLANNED VITRECTOMY WAS DUE TO A CAPSULE TEAR DURING THE REMOVAL OF THE DAMAGED LENS, AND THE MEDICATION PRESCRIBED WAS OUTSIDE OF THE STANDARD POST-OPERATIVE CARE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 22948657 ↗