ACRYSOFRecalls & reported problems across all models
Alcon Laboratories, Inc. · 353 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,890
- Deaths reported
- 0
- Injuries reported
- 539
- Recalls
- 0
We found 353 models of ACRYSOF by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 1,890 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2015 and Sep 25, 2026 — classified as 539 injuries, 1,350 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (263 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ACRYSOF problems
Device problems
- Adverse Event Without Identified Device or Use Problem345
- Scratched Material263
- Break220
- Defective Device210
- Material Split, Cut or Torn101
- Device Contamination with Chemical or Other Material94
- Crack88
- Material Twisted/Bent81
Patient problems
- Insufficient Information718
- No Clinical Signs, Symptoms or Conditions665
- Blurred Vision178
- Visual Impairment151
- Visual Disturbances99
- Capsular Bag Tear77
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available71
- Eye Injury33
ACRYSOF models
353 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- ACRYSOF® SN60WFintraocular lens46 reports
- ACRYSOF® SN60WFintraocular lens46 reports
- ACRYSOF® SN60WFintraocular lens44 reports
- ACRYSOF® SN60WFintraocular lens42 reports
- ACRYSOF® SN60WFintraocular lens42 reports
- ACRYSOF® SA60ATintraocular lens40 reports
- ACRYSOF® SN60WFintraocular lens39 reports
- ACRYSOF® SA60ATintraocular lens37 reports
- ACRYSOF® SA60ATintraocular lens37 reports
- ACRYSOF® SN60WFintraocular lens36 reports
- ACRYSOF® SA60ATintraocular lens35 reports
- ACRYSOF® SN60WFintraocular lens33 reports
- ACRYSOF® SA60ATintraocular lens31 reports
- ACRYSOF® SA60WFintraocular lens30 reports
- ACRYSOF® SN60WFintraocular lens29 reports
- ACRYSOF® SA60ATintraocular lens26 reports
- ACRYSOF® SN60WFintraocular lens26 reports
- ACRYSOF® SN60WFintraocular lens26 reports
- ACRYSOF® SA60WFintraocular lens25 reports
- ACRYSOF® SN60WFintraocular lens24 reports
- ACRYSOF® SN60WFintraocular lens22 reports
- ACRYSOF® SN60WFintraocular lens22 reports
- ACRYSOF® SA60WFintraocular lens21 reports
- ACRYSOF® SN60WFintraocular lens21 reports
- ACRYSOF® SA60WFintraocular lens20 reports
- ACRYSOF® SA60ATintraocular lens20 reports
- ACRYSOF® SA60ATintraocular lens20 reports
- ACRYSOF® SA60ATintraocular lens20 reports
- ACRYSOF® SA60ATintraocular lens19 reports
- ACRYSOF® SA60WFintraocular lens18 reports
- ACRYSOF® SA60WFintraocular lens17 reports
- ACRYSOF® SA60ATintraocular lens17 reports
- ACRYSOF® SA60ATintraocular lens16 reports
- ACRYSOF® SA60WFintraocular lens15 reports
- ACRYSOF® SN60WFintraocular lens15 reports
- ACRYSOF® SN6AT4intraocular lens14 reports
- ACRYSOF® SA60WFintraocular lens14 reports
- ACRYSOF® SN60WFintraocular lens14 reports
- ACRYSOF® SN6AT4intraocular lens13 reports
- ACRYSOF® SA60ATintraocular lens13 reports
- ACRYSOF® SA60ATintraocular lens12 reports
- ACRYSOF® SN60WFintraocular lens12 reports
- ACRYSOF® SN6AT3intraocular lens11 reports
- ACRYSOF® SN6AT3intraocular lens11 reports
- ACRYSOF® SN6AT4intraocular lens11 reports
- ACRYSOF® SN6AT4intraocular lens11 reports
- ACRYSOF® SA60WFintraocular lens11 reports
- ACRYSOF® SA60WFintraocular lens11 reports
- ACRYSOF® SN60WFintraocular lens11 reports
- ACRYSOF® SA60ATintraocular lens10 reports
- ACRYSOF® SN6AT3intraocular lens10 reports
- ACRYSOF® SN6AT4intraocular lens10 reports
- ACRYSOF® SA60WFintraocular lens10 reports
- ACRYSOF® SA60WFintraocular lens10 reports
- ACRYSOF® SA60ATintraocular lens10 reports
- ACRYSOF® SA60ATintraocular lens10 reports
- ACRYSOF® SN60WFintraocular lens10 reports
- ACRYSOF® SN60WFintraocular lens10 reports
- ACRYSOF® SN6AT3intraocular lens9 reports
- ACRYSOF® SN6AT4intraocular lens9 reports
- ACRYSOF® SN60WFintraocular lens9 reports
- ACRYSOF® SN6AT3intraocular lens8 reports
- ACRYSOF® SN6AT4intraocular lens8 reports
- ACRYSOF® SA60WFintraocular lens8 reports
- ACRYSOF® SA60ATintraocular lens8 reports
- ACRYSOF® SA60ATintraocular lens8 reports
- ACRYSOF® SN6AT4intraocular lens7 reports
- ACRYSOF® SA60WFintraocular lens7 reports
- ACRYSOF® SN60WFintraocular lens7 reports
- ACRYSOF® SN6AT3intraocular lens6 reports
- ACRYSOF® SN6AT3intraocular lens6 reports
- ACRYSOF® SN6AT3intraocular lens6 reports
- ACRYSOF® SN6AT3intraocular lens6 reports
- ACRYSOF® SN6AT5intraocular lens6 reports
- ACRYSOF® SN6AT5intraocular lens6 reports
- ACRYSOF® SA60WFintraocular lens6 reports
- ACRYSOF® SA60WFintraocular lens6 reports
- ACRYSOF® SN60WFintraocular lens6 reports
- ACRYSOF® SN60ATintraocular lens5 reports
- ACRYSOF® SN60ATintraocular lens5 reports
- ACRYSOF® SN60ATintraocular lens5 reports
- ACRYSOF® SN6AT3intraocular lens5 reports
- ACRYSOF® SN6AT4intraocular lens5 reports
- ACRYSOF® SN6AT4intraocular lens5 reports
- ACRYSOF® SN6AT5intraocular lens5 reports
- ACRYSOF® SN6AT5intraocular lens5 reports
- ACRYSOF® SA60WFintraocular lens5 reports
- ACRYSOF® SA60WFintraocular lens5 reports
- ACRYSOF® SA60ATintraocular lens5 reports
- ACRYSOF® SN60WFintraocular lens5 reports
- ACRYSOF® SN60WFintraocular lens5 reports
- ACRYSOF® SN60WFintraocular lens5 reports
- ACRYSOF® SA60ATintraocular lens4 reports
- ACRYSOF® SA60ATintraocular lens4 reports
- ACRYSOF® SN6AT3intraocular lens4 reports
- ACRYSOF® SN6AT3intraocular lens4 reports
- ACRYSOF® SN6AT3intraocular lens4 reports
- ACRYSOF® SN6AT3intraocular lens4 reports
- ACRYSOF® SN6AT3intraocular lens4 reports
- ACRYSOF® SN6AT4intraocular lens4 reports
Recent ACRYSOF adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Failure to Deliver
A health care professional reported that during an intraocular lens (IOL) implant procedure, lens appeared hard/stiff and was very difficult to advance through the cartridge. They attempted to use both BSS (Balanced salt solution) and company viscoelastic; however, the lens remained stiff and the lens did not deploy.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50898919 ↗MalfunctionSep 25, 2026Scratched Material
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, while loading the lens was found to be scratched/damaged. The procedure was completed on the same day. There was no contact between the patient eye and the device. The surgeon believed the lens was defective.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894918 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
A health care professional reported that a crack was observed in the intraocular lens (IOL). Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50867846 ↗MalfunctionSep 23, 2026Product Quality Problem
A health care professional reported with the description of intraocular lens (IOL) was defective (not specified).Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50867620 ↗MalfunctionSep 22, 2026Product Quality Problem
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, The implanted IOL was unusable upon/after implantation. The physician removed the lens and implanted a new replacement lens.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50855327 ↗MalfunctionSep 18, 2026Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826528 ↗MalfunctionSep 18, 2026Material Twisted/Bent
A healthcare professional reported with a description of the haptic became attached to the tip of the injector and subsequently detached.Additional information has been received and stated that noticed the issue when the lens was inside the cartridge and about to insert into patient's eye. The trailing haptic was stuck. Procedure complete on the same day with backup lens.
Patient problems: Insufficient Information
MAUDE report 50818472 ↗InjurySep 18, 2026Device Dislodged or Dislocated
A non-healthcare professional reported that following an intraocular lens (IOL) implantation procedure, a posteriorly dislocated lens was observed, with an open fundus in the affected eye, and surgical repair of the eye was planned. Surgery was recommended. Under local anesthesia, the eye was prepared and draped following periocular cleaning. The eyelids were opened using an eye speculum, and side-port openings were created with an MVR (Micro Vitreoretinal Blade) instrument. A 2.8 mm main incision was made, through which the dislocated lens was removed. An anterior vitrectomy was then performed, and a three-piece intraocular lens was implanted in the sulcus. The main incision was secured with a single suture. Following a subconjunctival antibiotic injection, a leak test was performed, and the procedure was completed successfully. The diagnosis included blepharoconjunctivitis and post-surgical cataract.Additional information was requested and received, stating that the lens was removed from the patient's eye, discarded during the surgery, and thrown away. The patient's condition was very poor. The surgeon informed the patient that nothing more could be done for that eye and that the
Patient problems: Conjunctivitis; Posterior Capsule Opacification
MAUDE report 50814632 ↗MalfunctionSep 4, 2026Break; Failure to Deliver
A non healthcare professional reported that during an intraocular lens implantation surgery the lens haptic gets stuck in the injector, causing the haptic to break when the injector was retracted.Surgery was completed on the same day by using the replacement lens.
Patient problems: Insufficient Information
MAUDE report 50614435 ↗MalfunctionAug 28, 2026Scratched Material
Patient problems: Insufficient Information
MAUDE report 50497675 ↗MalfunctionAug 28, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50493654 ↗MalfunctionAug 27, 2026Material Split, Cut or Torn
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed part of the lens broke and would not deploy, deemed defective. The lens was explanted during initial procedure. The procedure was completed on same day by using another lens with same diopter and model. Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474927 ↗MalfunctionAug 25, 2026Failure to Unfold or Unwrap
A non-health care professional reported with a description that, the implant had one of it's haptics which was found to be fused to the optic, thereby preventing its normal use. According to the surgeon, this type of defect has never been encountered during many years of experience using the company intraocular lenses. Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50431131 ↗MalfunctionAug 14, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251389 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
A report was received from the health authority and reported following an intraocular lens (IOL) implant procedure, the patient experienced hypersensitive to light both indoor lighting and especially sunlight. The patient experienced these after her cataract surgery in 2022. When the patient was outdoors, she wears sunglasses fitted by an optician with wide temples and they do not help. In (b)(6) 2026, she visited an optician and according to the doctor there was nothing wrong with her eyes. After spending time outdoors, her eyes became extremely strained and afterward she had difficulty focusing on vision. The areas around her eyes become red and swollen and her eyes look tired and overworked. She becomes very fatigued and develops headaches, she cannot stay outdoors on a sunny day and becomes extremely tired. Patient feels that her life was limited by light sensitive eyes. Before the cataract surgery, she did not have these problems. Additional information was received and stated, patient was informed that the light sensitivity would improve after 6 weeks of surgery. However, she had experienced light sensitivity ever since and it was difficult to be outdoors in sunlight and dazz
Patient problems: Blurred Vision; Eye Pain; Headache; Visual Disturbances
MAUDE report 50234569 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
- ClearCut17 models · 531 reports · 13 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page