AcrySof® UltraSert® AU00T0 (UDI 00380652394826)Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00380652394826), received between Mar 19, 2021 and Sep 23, 2026 — classified as 8 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device Difficult to Setup or Prepare; Device Damaged by Another Device

  A non-health care professional reported that during an intraocular implantation procedure, the haptic caught on the delivery system plunger and did not release from the plunger, which resulted in haptic to tear/break off.Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50868877 ↗
• MalfunctionMay 14, 2026Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER DID NOT ADVANCE THE LENS. THERE WAS PATIENT CONTACT WITH DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THERE WAS NO PATIENT HARM AND SURGERY COMPLETED SAME DAY WITH REPLACEMENT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173278 ↗
• MalfunctionApr 22, 2026Failure to Deliver; Failure to Advance

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT ADVANCE AS PLUNGER WENT ON THE TOP BYPASSED THE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING SURGERY WAS ABLE TO BE COMPLETED WITH NEW LENS.

  Patient problems: Insufficient Information

  MAUDE report 24956269 ↗
• MalfunctionDec 23, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS BECAME TWISTED WITH THE PLUNGER INSIDE THE INJECTOR. THE PROCEDURE WAS COMPLETED USING A NEW IOL, AND THERE WAS NO PATIENT CONTACT WITH THE FAULTY LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876240 ↗
• MalfunctionDec 12, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23791581 ↗
• MalfunctionNov 28, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS THAT FAILED TO ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23672253 ↗
• MalfunctionNov 27, 2025Failure to Advance; Failure to Advance

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FAULTY AND PLUNGER OVER-RIDE THE LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A NEW LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665174 ↗
• MalfunctionNov 18, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, IOL PLUNGER MISPOSITIONED THE LENS IN THE NARROW PART OF THE CARTRIDGE, WHICH LED TO COMPRESSION AND DETACHMENT OF THE HAPTIC ELEMENT, AS WELL AS DAMAGE TO A SECTION OF THE OPTIC DURING ITS RELEASE FROM THE DEVICE. THERE WAS NO PATIENT CONTACT AND HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589939 ↗
• MalfunctionNov 12, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE LENS WAS DAMAGED/BROKEN WHEN THE PRODUCT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530019 ↗
• MalfunctionNov 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A CLINICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WAS PRIMED AND DEPRESSED; HOWEVER, IT EXHIBITED NO RESISTANCE. AS A RESULT, THE LENS ADHERED TO THE PLUNGER AND REMAINED VISIBLE WITHIN THE CARTRIDGE. UPON INSERTION, THE LENS WOULDN'T SIT CORRECTLY AND WAS SUBSEQUENTLY REMOVED DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT LENS ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 23497966 ↗
• MalfunctionAug 5, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT, DURING CALIBRATION THE HAPTICS WERE IN THE WRONG POSITION AND TORN, SO THE SURGEON WAS UNABLE TO USE THE LENS, AND IT WAS DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 22715386 ↗
• MalfunctionAug 4, 2025Break; Break

  A PHYSICIAN REPORTED THAT THE LENS WITH THE BROKEN HAPTIC WAS DELIVERED TO THE CONSUMABLES UNIT IN ITS BOX. THERE WAS PATIENT CONTACT. NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WITH A BROKEN POSTERIOR HAPTIC. THE EVENT OCCURRED DURING THE CATARACT SURGERY TO THE RIGHT EYE. ANY HARM TO THE PATIENT WAS NOTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700719 ↗
• MalfunctionJul 4, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  AN ADMINISTRATOR/SUPERVISOR (HEALTHCARE PROFESSIONAL) REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE PLUNGER WENT OVER THE LENS, IT DAMAGED POSTERIOR HAPTIC OF THE LENS AND COULD NOT BE INSERTED. THE LENS WAS NOT IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED LENS ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403733 ↗
• MalfunctionApr 25, 2025Failure to Deliver; Failure to Deliver

  A PHYSICIAN REPORTED WITH A DESCRIPTION, LENS GOT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED, THE SURGERY WAS COMPLETED WITH ANOTHER LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21908212 ↗
• MalfunctionApr 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF TRAILING HAPTIC TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864040 ↗
• MalfunctionApr 18, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT, LENS NOT ADVANCING. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS A PATIENT CONTACT WITH THE INJECTOR HOWEVER NOT WITH THE LENS AS THE LENS WOULD NOT PROCEED. THE INJECTOR WAS REMOVED DURING THE PROCEDURE AND REPLACED BY NEW LENS.

  Patient problems: Insufficient Information

  MAUDE report 21863721 ↗
• MalfunctionMar 24, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS PLUNGER FAILED TO ADVANCE FULLY AND FAILED TO DEPLOY THE LENS. THEY WITHDREW THE PLUNGER SLIGHTLY AND TRIED ADVANCING AGAIN AND IT GOT STUCK AGAIN. THEY HANDED OVER THE INTRODUCER TO THE SURGEON WHO TRIED TO ADVANCE, THEN FLIPPED OPEN THE END CARTRIDGE WHERE THE LENS WAS, TO SEE WHAT WAS STOPPING THE PLUNGER. SURGEON WAS UNABLE TO MAKE IT WORK. THE PROCEDURE WAS COMPLETED BY USING UNSPECIFIED REPLACEMENT IOL.

  Patient problems: Insufficient Information

  MAUDE report 21679369 ↗
• MalfunctionMar 24, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT ONE OF THE HAPTICS OF THE LENS WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED REPLACEMENT IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676643 ↗
• MalfunctionMar 18, 2025Inaccurate Information; Inaccurate Information

  A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY THEY HAVE NOTICED THAT THE SERIAL NUMBER (SN) ON LENS DOES NOT MATCH SN ON THE BOX, PACKAGING DEFAULT. THERE WAS NO PATIENT CONTACT AND NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632482 ↗
• MalfunctionMar 14, 2025Defective Component; Device Damaged by Another Device; Defective Component; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION FAULTY LENS/INJECTOR. ADDITIONAL INFORMATION RECEIVED THAT THE TRAILING HAPTIC TRAPPED IN THE INJECTOR AND TIP OF INJECTOR GOT SNAPPED. THE LENS WAS SETTLED IN THE BAG AND WAS STABLE. THERE WAS NO PATIENT HARM. THE SURGEON PLANS TO EXPLANT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604502 ↗
• MalfunctionFeb 25, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WENT WRONG IN THE INJECTOR OR LEADING HAPTIC ERROR. THE PROCEDURE WAS COMPLETED ON SAME DAY BY USING UNSPECIFIED REPLACEMENT IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS FILE IS 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460856 ↗
• MalfunctionFeb 25, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WENT WRONG IN THE INJECTOR, LEADING HAPTIC ERROR. THE PROCEDURE WAS COMPLETED ON SAME DAY BY USING UNSPECIFIED REPLACEMENT IOL. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS FILE IS 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458783 ↗
• MalfunctionDec 27, 2024Device Damaged Prior to Use; Failure to Eject; Device Damaged Prior to Use; Failure to Eject

  A SURGEON REPORTED DURING A CATARACT REMOVAL AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN RIGHT EYE, WHILE PREPARING THE IOL FOR IMPLANTATION, THE SURGEON NOTICED THAT THE PLUNGER PASSED OVER THE IOL, PINCHING THE POSTERIOR HAPTIC AT THE CARTRIDGE'S EXIT WITH CONFIRMED NO PATIENT CONTACT. THE LENS WAS REPLACED WITH IDENTICAL REPLACEMENT LENS AND THE PROCEDURE WAS COMPLETED ON SAME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027085 ↗
• MalfunctionDec 12, 2024Defective Component; Device Damaged by Another Device; Defective Component; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION FAULTY LENS/INJECTOR. ADDITIONAL INFORMATION RECEIVED THAT THE TRAILING HAPTIC TRAPPED IN THE INJECTOR AND TIP OF INJECTOR GOT SNAPPED. THE LENS WAS SETTLED IN THE BAG AND WAS STABLE. THERE WAS NO PATIENT HARM. THE SURGEON PLANS TO EXPLANT LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915992 ↗
• MalfunctionDec 6, 2024Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS IMPLANT PROCEDURE THE SURGEON TRIED TO ADVANCE THE LENS BUT PLUNGER HAD PIERCED THE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863647 ↗