AcrySof® UltraSert® AU00T0 (UDI 00380652394871)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652394871), received between Mar 19, 2021 and Apr 6, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Product Quality Problem; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PHAKIC INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE OPTIC WAS TORN AND DEFORMED AFTER THE IOL HAD BEEN IMPLANTED INTO THE EYE. THE LENS WAS CUT AND EXPLANTED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789428 ↗
• MalfunctionNov 28, 2025Break; Failure to Fold; Device Damaged by Another Device; Break; Failure to Fold; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL PLUNGER INCORRECTLY POSITIONED THE LENS IN THE NARROW PART OF THE CARTRIDGE, WHICH LED TO ENTRAPMENT AND DETACHMENT OF THE HAPTIC ELEMENT, AS WELL AS DAMAGE TO A SECTION OF THE OPTICAL PART OF THE IOL DURING ITS EXIT FROM THE DEVICE. COMPANY VISCOELASTIC WAS USED AT ALL STAGES OF THE PROCEDURE. THE SURGERY WAS COMPLETED WITH THE BACKUP COMPANY LENS OF SAME DIOPTER. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671936 ↗
• MalfunctionAug 19, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DIDN'T HAD A PIECE (HAPTIC BROKEN) AND THE PATIENT WAS SEDATED. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837224 ↗
• MalfunctionAug 6, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LEADING HAPTIC WAS TWISTED. THE SURGERY WAS COMPLETED USING A BACKUP LENS WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726871 ↗
• InjuryDec 7, 2023Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DID NOT FOLD CORRECTLY, STRAIGHT LEADING HAPTIC. THE LENS WAS IMPLANTED. PROCEDURE WAS COMPLETED AND CORNEAL ENDOTHELIUM DAMAGE WAS NOTED AT POST OP VISIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Endothelial Cell Loss

  MAUDE report 18282578 ↗
• MalfunctionSep 8, 2023Defective Component; Failure to Eject; Defective Component; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC OF THE LENS WAS INITIALLY POSITIONED STRAIGHT IN THE INSERTER. WHEN THE DOCTOR WAS INJECTING THE LENS, THE HAPTIC REMAINED OUTSIDE THE WOUND, AND UPON CONTACT WITH THE ASSISTING INSTRUMENT, THE HAPTIC SNAPPED. CONSEQUENTLY, THE LENS WAS REMOVED, AND A NEW LENS WAS SUCCESSFULLY IMPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATE THAT, THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711720 ↗
• MalfunctionJul 11, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED AS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE SCHEDULED PROCEDURE WAS COMPLETED ON SAME DAY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296599 ↗
• MalfunctionJul 7, 2023Failure to Eject; Failure to Eject

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED ABOUT A LENS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING LENS STUCK IN THE INJECTOR DURING INSERTION. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH BACK UP LENS.

  Patient problems: Insufficient Information

  MAUDE report 17276873 ↗
• MalfunctionApr 23, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A MATERIALS MANAGEMENT REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DIDN¿T UNFOLD PROPERLY. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792871 ↗
• InjuryApr 4, 2023Unintended Ejection; Unintended Ejection

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IOL IMMEDIATELY RELEASED DUE TO SUDDEN STEP PUSH OF THE INJECTOR, RESULTED IN CAPSULE TO BREAK. THE DISTAL HAPTIC WAS STRAIGHT. DUE TO CAPSULE BREAK, ANTERIOR VITRECTOMY WAS PERFORMED AND AN IOL WAS IMPLANTED IN SULCUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT CONDITION WAS GOOD AFTER SURGERY.

  Patient problems: Capsular Bag Tear

  MAUDE report 16672115 ↗
• MalfunctionMar 21, 2023Unintended Ejection; Defective Component; Unintended Ejection; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE HAPTIC SLIGHTLY TOUCHED THE CORNEA/CORNEAL ENDOTHELIUM BECAUSE THE TIP OF THE CARTRIDGE ONLY GOES INTO THE INCISION TO A VERY LIMITED EXTENT DUE TO THE WOUND STOPPER ON THE CARTRIDGE AND THE HAPTIC WAS NOT PROPERLY INSERTED AND STRETCHED. POST OP EXAMINATION DID NOT SHOW ANY DAMAGE TO THE CORNEA AND VISUAL ACUITY WAS FINE. THERE WAS NO PATIENT HARM. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LEADING HAPTIC WAS EFFECTED AND SLIGHTLY TOUCHED CORNEA/CORNEAL ENDOTHELIUM. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND NO INTERVENTION WAS NEEDED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580731 ↗
• MalfunctionJun 16, 2021Difficult to Insert; Inaccurate Delivery; Scratched Material; Difficult to Insert; Inaccurate Delivery; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT AN INTRAOCULAR LENS (IOL) WOULD NOT LOAD. THERE WAS PATIENT CONTACT AND NO INFORMATION WAS REPORTED RELATED TO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007685 ↗
• MalfunctionMar 19, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A CUSTOMER REPORTED THE PLUNGER OF A PRELOADED INTRAOCULAR LENS (IOL) DELIVERY SYSTEM WAS STIFF. THERE WAS NO REPORTED PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530918 ↗
• MalfunctionMar 19, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  A CUSTOMER REPORTED THE PLUNGER OF A PRELOADED INTRAOCULAR LENS (IOL) DELIVERY SYSTEM WAS STIFF. THERE WAS NO REPORTED PATIENT IMPACT HOWEVER THE EYE DID 'JOLT'. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 11530917 ↗