AcrySof® UltraSert® AU00T0 (UDI 00380652394734)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380652394734), received between May 5, 2021 and May 19, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS FAULTY - THE LENS HAPTIC WAS BROKEN. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE EVENT OCCURRED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A NEW LENS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216982 ↗
• MalfunctionDec 26, 2025Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CAME OUT BROKEN FROM THE CARTRIDGE AFTER THE PRODUCT WAS OPENED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896447 ↗
• MalfunctionNov 12, 2025Break; Break

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS BROKEN. THE PRODUCT WAS NOT APPLIED ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530740 ↗
• MalfunctionOct 24, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NURSE REPORTED THAT A LENS OPENED RECENTLY BY ONE OF OUR SCRUB NURSES. ON OPENING THE LENS WAS FOUND TO ONLY HAVE ONE HAPTIC.

  Patient problems: Insufficient Information

  MAUDE report 23379530 ↗
• MalfunctionAug 7, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS HAD A DEFECT (A CRACK IN THE OPTICAL ZONE). THE PROCEDURE WAS COMPLETED WITH NEW IOL. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738335 ↗
• MalfunctionAug 9, 2024Defective Device; Defective Device

  A PHARMACIST REPORTED THAT DURING SURGERY, THEY NOTICED THAT A DEFECTIVE IMPLANT AT TIME OF PLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19948372 ↗
• MalfunctionJun 13, 2024Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL VIA REGULATORY AGENCY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS CHECKED AGAINST THE BIOMETRY BEFORE OPENING. UPON INSERTION OF THE LENS BY THE SURGEON, THE LENS FAILED TO THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS. PROCEDURE CARRIED OUT WITHOUT ANY UNTOWARD INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528615 ↗
• MalfunctionMay 21, 2024Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, DAMAGED LENS WAS DISCARDED ON THE DAY OF SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19357863 ↗
• MalfunctionMar 13, 2024Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS WOULD NOT COME OUT OF THE INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED AND NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18895450 ↗
• MalfunctionDec 27, 2023Failure to Eject; Physical Resistance/Sticking; Failure to Eject; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS MOVED VERY SLUGGISHLY AND THE PLUNGER HAD TO BE PUSHED FORWARD WITH FORCE. THE DOCTOR COULDN'T PLACE THIS LENS IN THE EYE. THE PROCEDURE COMPLETED WITH THE REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18396753 ↗
• MalfunctionDec 27, 2023Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER TWISTED FORWARD, FORCING THE LENS TO THE RIGHT SIDE AND THE DIRECTION DID NOT STRAIGHTEN EVEN WHEN PULLING THE PLUNGER BACKWARD. THE PROCEDURE COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18396752 ↗
• MalfunctionDec 20, 2023Defective Component; Defective Component

  A PHYSICIAN REPORTED WITH DESCRIPTION DEFECTIVE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18361718 ↗
• MalfunctionApr 21, 2023Failure to Advance; Scratched Material; Failure to Advance; Scratched Material

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION INJECTOR HAS NOT ENGAGED THE LENS CAUSING THE SCRATCHING AND NOT ALLOWING IT TO BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16782708 ↗
• MalfunctionDec 27, 2022Break; Break

  A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE BROKEN. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052767 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ACCOUNT MANAGER REPORTED THAT FOLLOWING THE IMPLANTATION OF INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED ENDOPHALMITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT BELONGS TO PATIENT 3 OUT OF 4.

  Patient problems: Endophthalmitis

  MAUDE report 15427493 ↗
• MalfunctionJun 10, 2022Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  THE HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL GOT STUCK IN THE DEVICE AND WOULD NOT GO OUT DESPITE USING THE CORRECT VISCOELASTIC AND FOLLOWING PROPER STEPS. AFTER REMOVING THE IOL FROM THE INJECTOR, IT SHOWED THAT ONE HAPTIC WAS TWISTED WHICH WAS THE REASON WHY IT WAS STUCK. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652525 ↗
• MalfunctionApr 19, 2022Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS SHOT OUT AND THE HAPTIC APPEARED TO BE BENT OVER THE LENS. THE LENS WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 14141960 ↗
• InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING A CATARACT EXTRACTION PROCEDURE. UPON EXAMINATION OF THE PATIENT, THE SURGEON NOTED 2+ AQUEOUS CELL, AQUEOUS FIBRIN, HYPOPYON, 1+ CONJUNCTIVAL AND 1+VITREOUS INFLAMMATION. THE PATIENT WAS PRESCRIBED WITH POST-OPERATIVE ANTIBIOTIC, STEROID (TOBRAMYCIN/DEXAMETHASONE) AND NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (LIDOCAINE). NO CULTURES WERE PERFORMED. THE PATIENT'S SYMPTOMS HAVE BEEN CONTINUING WITH TOPICAL MEDICATION. THIS IS THE SECOND OF THREE REPORTS FOR THIS EVENT.

  Patient problems: Hypopyon; Inflammation; Toxic Anterior Segment Syndrome (TASS); Uveitis

  MAUDE report 13683946 ↗
• MalfunctionFeb 10, 2022Defective Component; Failure to Eject; Defective Component; Failure to Eject

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THERE WAS CHALLENGES WITH THE PLUNGER BUT SURGEON DECIDED TO USE THE DEVICE ANYWAY. THE DEVICE WAS PREPARED NORMALLY ACCORDING TO INSTRUCTIONS AND PUSHED PLUNGER FORWARD AND NOTICED THAT PLUNGER WAS SLIDING ON TOP OF THE LENS. THE TECHNICIAN PULLED THE PLUNGER BACK AND ASKED THE SURGEON TO CHECK THE LENS. THE SURGEON INSPECTED THE LENS AND SAID THE LENS COULD STILL BE USED. THE SURGEON PUSHED PLUNGER FORWARD AND THIS TIME PLUNGER PUSHED THE LENS FORWARD AS IT SHOULD. THE LENS WAS PLACED IN THE EYE BUT THE TRAILING HAPTIC OF THE LENS WAS NOT PROPERLY FOLDED INSIDE THE LENS BUT WAS STUCK BETWEEN THE PLUNGER AND THE TIP OF THE DELIVERY SYSTEM. LENS WAS FREED FROM THE DELIVERY SYSTEM WITH FORCEPS. THE LENS REMAINED UNDAMAGED AND THE LENS WAS FITTED TO THE EYE. THE SURGEON HAD USED FORCEPS WAS USED TO REMOVE THE HAPTIC FROM BETWEEN THE INJECTOR TIP AND PLUNGER. THE LENS REMAINED UNDAMAGED AND THE LENS WAS FITTED TO THE EYE USING AN AUXILIARY INSTRUMENT. THE IS NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13504369 ↗
• MalfunctionNov 29, 2021Material Twisted/Bent; Failure to Eject; Material Twisted/Bent; Failure to Eject

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PLUNGER DID NOT PUSH THE LENS THROUGH THE HAPTIC, IT HAD PUSHED THROUGH THE OPTIC AREA. IT WAS ALSO REPORT THAT THE LENS WAS IMPLANTED WITHOUT ANY PROBLEM, HOWEVER THE SECOND HAPTIC WAS OUT OF THE INCISION AND THE PHYSICIAN HAD TO REPOSITION IT. ADDITIONAL INFORMATION RECEIVED BY SURGEON THAT, THE PLUNGER CAME OUT CROOKED, AND DID NOT PUSH THE HAPTIC, BUT PUSHED THE OPTIC, CAUSING THE SECOND HAPTIC TO COME OUT STRANGE AND ALMOST OUT OF THE EYE. THE LENS WAS IMPLANTED WITH A LITTLE MANIPULATION BY THE DOCTOR. THAT THE INJECTOR DID NOT DRAG THE LENS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883845 ↗
• MalfunctionMay 12, 2021Failure to Advance; Failure to Eject; Failure to Advance; Failure to Eject

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TIP OF THE INJECTOR WAS ALREADY IN THE PATIENT EYE AS THE PLUNGER PASSED THE LENS AND LEAVING THE LENS IN THE INJECTOR. REPLACEMENT PRODUCT WAS INTRODUCED AND PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO HARM TO PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813767 ↗
• MalfunctionMay 5, 2021Inaccurate Delivery; Inaccurate Delivery

  THE REPRESENTATIVE REPORTED THAT THEY HAVE EXPERIENCED ISSUES WITH THE INJECTORS RIDING OVER THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11777696 ↗