AcrySof® UltraSert® ACU0T0 (REF ACU0T0.215)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Single-Piece Posterior Chamber Lenses with the UltraSert® Pre-loaded Delivery System · Class 3 · Implant
All models of AcrySof UltraSert (102)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof UltraSert intraocular lens is a foldable acrylic lens used in cataract surgery, preloaded in an injector cartridge. The 37 reports mostly describe delivery problems during implantation: the lens sticking, crumpling or failing to unfold or advance through the injector, and cracking or chipping at the haptic edge. Two injuries were reported and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380652395281), received between Apr 28, 2021 and Sep 28, 2026 — classified as 2 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (7 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver7
- Defective Device6
- Device Difficult to Setup or Prepare6
- Appropriate Device Problem Term/Code Not Available5
- Failure to Unfold or Unwrap5
- Failure to Advance4
- Device Damaged by Another Device3
- Failure to Eject3
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information11
- Blurred Vision1
- Capsular Bag Tear1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Twisted/Bent
A health care professional reported that during an intraocular lens (IOL) implant procedure, trailing haptic remained straight during injection and could not be placed into the eye, which required opening a new intraocular lens.Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50914303 ↗MalfunctionMay 8, 2026Failure to Deliver
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BECAME STUCK DURING INJECTION. THE SURGERY COMPLETED WITH REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25125699 ↗MalfunctionMar 26, 2026Failure to Advance; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT WHILE LOADING THE BLUE PLUNGER IT INITIALLY PUSHED THE LENS FORWARD, BUT THEN IT CONTINUED ITS MOVEMENT WITHOUT THE LENS, LEAVING IT CRUMPLED TO THE SIDE. DUE TO THE RISK THAT THE LENS MIGHT HAVE BEEN SCRATCHED, THE SURGEON HAD CHOSEN ANOTHER LENS RATHER THAN ATTEMPTING TO RELOAD IT. THE PROCEDURE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT STATED THAT THE TIP DID NOT COME INTO CONTACT WITH THE PATIENT¿S EYE BECAUSE THE SCRUB NURSE NOTICED THAT THE LENS HAD NOT BEEN ENGAGED BY THE PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700325 ↗MalfunctionMar 17, 2026Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, A CRACK WAS NOTICED AT THE HAPTIC-OPTIC JUNCTION, RAISING CONCERNS ABOUT POSSIBLE POSTOPERATIVE VISUAL IMPACT. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24616985 ↗MalfunctionFeb 27, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SMALL DAMAGE ON THE EDGE OF THE HAPTIC, LEFT IT IN PATIENT SINCE REMOVING IT WOULD BE MORE INTRUSIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24472423 ↗MalfunctionDec 17, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION THE PLUNGER CAPTURED THE HAPTIC, THEN BROKE. THE LENS WAS IMPLANTED AND REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH NEW LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT HAD A CONTACT WITH IOL BUT NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829134 ↗MalfunctionAug 26, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A CONSUMER WHO IS ALSO A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22895874 ↗MalfunctionJul 9, 2025Failure to Prime; Device Damaged by Another Device; Failure to Prime; Device Damaged by Another Device
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS CROOKED IN THE INJECTOR, IT WAS DIFFICULT TO PUSH FORWARD AND COULD NOT BE IMPLANTED. THE CATARACT SURGERY WAS COMPLETED WITH A UNSPECIFIED REPLACEMENT PRODUCT. THERE WAS NO PATIENT CONTACT AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459455 ↗MalfunctionJul 9, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT WHEN THE LENS WAS INJECTED IT TO THE EYE IT WAS NOTED HALF THE TRAILING HAPTIC WAS LEFT STUCK IN INJECTOR. SURGEON LEFT THE LENS IN PATIENT¿S EYE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22455612 ↗MalfunctionJul 8, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY, BROKEN HAPTIC WAS NOTICED WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22439861 ↗MalfunctionJul 3, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A FAULTY LENS HAPTIC WHICH WAS INSIDE THE DEVICE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393976 ↗MalfunctionApr 22, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN CARTRIDGE / LENS WOULD NOT ADVANCE. THE PROCEDURE WAS COMPLETED ON SAME DAY BY USING UNSPECIFIED REPLACEMENT IOL.
Patient problems: Insufficient Information
MAUDE report 21881810 ↗MalfunctionMar 21, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FOLLOWING DELIVERY OF LENS INTO THE EYE IT WAS DISCOVERED THAT THE LENS HAD A SCRATCH ON IT. THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED SAME DIOPTER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21661452 ↗MalfunctionFeb 20, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS GOT STUCK IN THE INJECTOR. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21419436 ↗MalfunctionFeb 18, 2025Device Difficult to Setup or Prepare; Failure to Deliver; Device Difficult to Setup or Prepare; Failure to Deliver
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INTRAOCULAR LENS (IOL) BLOCKED IN INJECTOR AND HIGH RESISTANCE WHEN MOVING THE PLUNGER. IOL IMPLANTATION WAS ABANDONED AND SURGERY WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397843 ↗MalfunctionFeb 18, 2025Device Difficult to Setup or Prepare; Failure to Deliver; Device Difficult to Setup or Prepare; Failure to Deliver
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INTRAOCULAR LENS (IOL) BLOCKED IN INJECTOR AND HIGH RESISTANCE WHEN MOVING THE PLUNGER. IOL IMPLANTATION WAS ABANDONED AND SURGERY WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENTS. THIS FILE IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397581 ↗InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 19 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTIVE SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 21158656 ↗MalfunctionOct 30, 2024Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR WAS MALFUNCTIONING, INJECTOR DID NOT HOOK THE LENS AND MARKED IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570517 ↗MalfunctionSep 25, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20300264 ↗MalfunctionAug 6, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE SECOND HAPTIC GOT STUCK INSIDE THE BARREL. THE LENS IS ALREADY HALF WAY OUT BUT WONT COME OUT COMPLETELY. PATIENT CONTACT OCCURRED. NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919467 ↗MalfunctionMay 24, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER DID NOT ENGAGE WITH THE IOL AND DID NOT ADVANCE THE LENS FORWARD. THE LENS WAS ABANDON AND USED NEW LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391678 ↗MalfunctionNov 2, 2023Dent in Material; Dent in Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY OBSERVED ABNORMAL APPEARANCE CLOSEST TO OUTER EDGE OF THE LENS AND OBSERVED AFTER IMPLANT, SUBSEQUENTLY, THE LENS WAS REMOVED DURING INITIAL PROCEDURE, PROCEDURE IS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18056456 ↗MalfunctionFeb 3, 2023Failure to Advance; Defective Device; Difficult to Advance; Failure to Advance; Defective Device; Difficult to Advance
A HEALTH PROFESSIONAL REPORTED THAT, DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DIDN¿T UNLOAD PROPERLY, LEADING HAPTIC STUCK. SURGEON UNABLE TO INJECT INTO PATIENTS CAPSULE BAG. THERE WAS PATIENT CONTACT NOTED HOWEVER NO PATIENT HARM. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16289122 ↗MalfunctionDec 14, 2022Unintended Ejection; Difficult to Advance; Unintended Ejection; Difficult to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CAME OUT OF THE INJECTOR WITH ROTATED HAPTICS, OPTIC COMING OUT ROTATED AND SHOOTING OUT OF THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15977252 ↗MalfunctionNov 9, 2022Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BLUE INJECTOR WAS STIFF AND LENS WOULD NOT ADVANCE. THE PROCEDURE WAS COMPETED BY USING NEW IOL. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15760970 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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