AcrySof IQ PanOptix Toric UV IOLRecalls & reported problems across all models
Alcon Laboratories, Inc. · 120 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 382
- Deaths reported
- 0
- Injuries reported
- 352
- Recalls
- 0
We found 120 models of AcrySof IQ PanOptix Toric UV IOL by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 382 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2021 and Aug 26, 2026 — classified as 352 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Defective Device” (16 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 IQ PanOptix Toric UV IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem303
- Defective Device16
- Device Dislodged or Dislocated16
- Malposition of Device16
- Scratched Material11
- Appropriate Device Problem Term/Code Not Available6
- Break4
- Failure to Advance3
Patient problems
- Blurred Vision196
- Visual Disturbances138
- Visual Impairment134
- Halo80
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available36
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information17
- Dry Eye(s)12
AcrySof IQ PanOptix Toric UV IOL models
120 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular18 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular16 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular14 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular14 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular12 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular11 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular11 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular10 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular8 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular8 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular8 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular8 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular8 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular7 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular7 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular6 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular6 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular6 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular6 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular5 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular5 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT60Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT60Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT60Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT60Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT60Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT60Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50Lens, multifocal intraocular1 report
Recent AcrySof IQ PanOptix Toric UV IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced poor vision and halos. Subsequently the lens was removed and replaced with an unspecified monofocal in a secondary procedure. The clinical reason for explant was intolerable to contrast and halos. Additional information has been requested but is not available at the time of this report. There are two Medical Device Reports associated with this report. This is 2 of 2.
Patient problems: Visual Disturbances
MAUDE report 50448578 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced poor vision and halos. Subsequently the lens was removed and replaced with an unspecified monofocal in a secondary procedure. The clinical reason for explant was intolerable to contrast and halos. Additional information has been requested but is not available at the time of this report. There are two Medical Device Reports associated with this report. This is 1 of 2.
Patient problems: Visual Disturbances
MAUDE report 50448575 ↗InjuryJul 25, 2025Material Twisted/Bent; Material Twisted/Bent
THE REPORT WAS RECEIVED FROM A GOVERNMENT AGENCY SHARING A MEDWATCH FORM, TO REPORT A PROBLEM RECEIVED FROM A PATIENT THAT, DOCTOR PERFORMED CATARACT SURGERY WITH COMPANY MULTI FOCAL LENS IN BOTH THE EYES. THE LENS IN THE LEFT EYE HAD NEVER WORKED. THE NEW LENS HAD CAUSED DOUBLE VISION AND BLURRED VISION IN THE LEFT EYE. REPORTED THIS TO THE DOCTOR AND HE SAID THAT THE NEW LENS WRINKLED WHEN IT WAS INSERTED. HE PERFORMED ANOTHER SURGERY TO CORRECT THE WRINKLE. THAT DID NOT CORRECT THE PROBLEM. CONSULTED TWO OTHER EYE DOCTORS, AND THEY AGREED THAT THE LENS WAS NOT WORKING BUT DID NOT TELL WHY THE LENS DID NOT WORK. THERE WAS A SPECULATION AS TO WHY THE BLURRED AND DOUBLE VISION. PROBLEM COULD BE THAT THE WRONG LENS WAS USED IN THE LEFT EYE; DOCTOR'S ASSISTANT COULD HAVE HANDED HIM THE WRONG LENS, LENS MIGHT HAVE NOT BEEN CORRECTLY MARKED IN THE PACKAGE BUT BOTTOM LINE THE VISION WAS NOT CORRECT IN THE LEFT EYE. THE DOCTOR THAT HE WAS SEEING PRESCRIBED A CONTACT LENS THAT MUST BE WORN DAILY. THIS WAS A CORRECTION LENS. BUT AS PER THE PATIENT, THE CATARACT SURGERY SHOULD HAVE CORRECTED THE VISION AND SHOULD NOT HAVE TO BUY CONTACT LENS FOREVER TO CORRECT THE VISION THAT SHOULD HAVE BE
Patient problems: Blurred Vision; Diplopia/Double Vision
MAUDE report 22608806 ↗InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH HAZY VISION AND POOR NEAR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 22 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS SUBJECTIVE VISUAL DISTURBANCE. ADDITIONAL INFORMATION WAS RECEIVED, AFTER REFRACTIVE LENS EXCHANGE PATIENT HAD YTTRIUM ALUMINUM GARNET (YAG) AFTER 12 WEEKS AND LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK) AFTER 16 WEEKS FOLLOWING THE INITIAL IMPLANT. PATIENT COULD NOT ADAPT TO LENS AND ALSO HAD SUBJECTIVE VISUAL DISTORTION. PATIENT ISSUES WERE RESOLVED AND THERE WAS NO PATIENT HARM. IN SURGEON PROGNOSIS VISUAL ACUITY WAS IMPROVING AND PATIENT WAITING FOR LIGHT ADJUSTMENTS TO THE NEWLY EXCHANGED LENS.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 21643790 ↗InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND POOR VISION, DESPITE YTTRIUM ALUMINUM GARNET (YAG) LASER CAPSULOTOMY THE IOL WAS EXCHANGED FOR MONOFOCAL IOL LENS 1 YEAR 2 MONTHS 3 WEEKS 2 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 21619461 ↗InjuryFeb 25, 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 BLURRED VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 4 MONTHS AND 14 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MECHANICAL COMPLICATION. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 21457460 ↗MalfunctionOct 25, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF DEFECT IN LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20539931 ↗InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS HYPEROPIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 20291918 ↗InjurySep 12, 2024Adverse 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 BLURRED VISION REFRACTIVE SURPRISE. CLINICAL REASON FOR EXPLANT WAS HYPEROPIA. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) COMPANY LENS 1 MONTH 03 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 20204738 ↗InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD VISUAL DISTURBANCES. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS REFRACTIVE ERROR.ADDITIONAL INFORMATION HAS BEEN REQUESTED.THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS 1 OF 2.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 20037714 ↗InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED POOR VISION. THE IOL WAS EXPLANTED AND EXCHANGED WITH NON COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAVE RECEIVED STATED THAT THE PATIENT WAS DISSATISFIED WITH GLARE. THE PATIENT DID NOT GET ADJUSTED TO LENS AND THERE WAS NO PATIENT HARM ONCE REMOVED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 19990457 ↗InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER LENS MODEL FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT NOT ADAPTING TO CURRENT IOL.
Patient problems: Visual Impairment
MAUDE report 19979309 ↗InjuryAug 13, 2024Adverse 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 VISION IMBALANCE, AND FELT RIGHT EYE WAS STRAINING MORE SINCE SURGERY. CLINICAL REASON FOR EXPLANT WAS REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR DIFFERENT MODEL AND DIOPTER, COMPANY LENS 4 MONTHS 13 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. TARGET WAS NOT ACHIEVED DURING INITIAL SURGERY BUT FOLLOWING IOL EXCHANGE THE PATIENT WAS HAPPY WITH THE VISION AND ISSUES WERE RESOLVED WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Pain; Visual Disturbances; Visual Impairment
MAUDE report 19973690 ↗InjuryJul 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON FOR EXPLANT MENTIONED AS REFRACTIVE ERROR. THE IOL WAS EXPLANTED AND EXCHANGED WITH NON COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED, PATIENT HAD HALOS AND GLARE AND REPORTED WITH NO PATIENT HARM.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 19870066 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS INSERTED A YEAR AGO, PATIENT HAD ISSUES WITH FOCUS, BLURRED VISION, DOUBLE VISION AND OTHER PROBLEMS. CONSUMER ALSO STATED LEFT EYE HAS BEEN RELATIVELY PROBLEM FREE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED DRYNESS, UNABLE TO READ AFTER A SHORT TIME MAYBE 30 MINUTES, FEELS INFLAMED AND IRRITATION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED WHEN PATIENT WAS SITTING TRYING TO READ. IF PATIENT CLOSE LEFT EYE JUST TO SEE HOW THE RIGHT EYE IS FUNCTIONING PATIENT HAD A TOTAL BLUR. CONSUMER CANNOT READ ANYTHING THROUGH THAT EYE.
Patient problems: Blurred Vision; Diplopia/Double Vision; Dry Eye(s); Eye Irritation; Visual Impairment
MAUDE report 19825806 ↗
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
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
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.
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