AcrySof Toric Aspheric UV Absorbing IOL SA6AT3 (REF SA6AT3.190)Recalls & reported problems
Alcon Laboratories, Inc. · The AcrySof Aspheric UV Absorbing Toric Posterior Chamber Intraocular Lens (IOL) is a UV Absorbing foldable intraocular lens (IOL) · Class 3 · Implant
All models of AcrySof Toric Aspheric UV Absorbing IOL (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652335744), received between Jan 31, 2022 and Oct 13, 2022 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (2 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.
Most reported problems
Device problems
- Failure to Advance2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Defective Device1
Patient problems
- Eye Injury2
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 13, 2022Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, IOL FOUND TO BE CRACKED THE PATIENT OUTCOME WAS GOOD. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15595392 ↗InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS EXPLANTED WITH A MONO FOCAL DUE TO PATIENT¿S REASONS OF BLURRY VISUAL ACUITY, ASTIGMATISM CHANGED FROM HORIZONTAL TO VERTICAL. CLINICAL REASON FOR THE EXPLANT WAS RESIDUAL/OVER CORRECTED ASTIGMATISM. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15231164 ↗MalfunctionMar 4, 2022Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED AND THE IOL WAS IMPLANTED AND EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13666789 ↗InjuryFeb 2, 2022Failure to Advance; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS HAD A CRACK. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT LENS WAS STUCK IN INCISION AND REMOVED WITHOUT DAMAGE. THE SURGEON MADE LARGER INCISION. IN SURGEONS OPINION THE LOADING ERROR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM OR HOSPITALIZATION FOR THE EVENT.
Patient problems: Eye Injury
MAUDE report 13423966 ↗InjuryJan 31, 2022Failure to Advance; Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS STUCK IN THE INCISION AND THE PHYSICIAN HAD TO ENLARGE THE INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED SATING THE LENS WAS REMOVED FROM THE INCISION WITHOUT CAUSING ANY DAMAGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Eye Injury
MAUDE report 13391113 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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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