ACRYSOF® SN6AT5 (REF SN6AT5.195)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 3.00 D CYLINDER. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652250986), received between May 31, 2022 and Jan 30, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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.
Reports received per month
Most reported problems
Device problems
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged by Another Device1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Zonular Dehiscence1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE PATIENT HAD ZONULYSIS HAPPENED WHEN DIALING THE LENS TO THE FINAL AXIS.
Patient problems: Zonular Dehiscence
MAUDE report 21273049 ↗InjuryDec 30, 2022Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT COMPLAINT ABOUT A SCRATCH ON THE LENS. THE SCRATCH WAS INFLUENCING HIS VISION. THE LENS WAS PLANNED TO REMOVE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, POST CATARACT SURGERY (WITH IOL IMPLANT) 1 WEEK FOLLOW UP, IT WAS FOUND THAT THE LENS THAT WAS INSERTED PRESENTED WITH A MARK IN THE OPTIC OF THE LENS, AFFECTING THE PATIENTS VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. THE ISSUE HAS BEEN RESOLVED.
Patient problems: Visual Disturbances
MAUDE report 16077323 ↗MalfunctionOct 3, 2022Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCHES WERE NOTED CENTRALLY ON THE INTRAOCULAR LENS, THEREFORE THE LENS WAS EXPLANTED AND DISCARDED. SUBSEQUENTLY, THE STANDBY IOL WAS IMPLANTED. THERE WAS A PATIENT CONTACT BUT NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15527962 ↗MalfunctionMay 31, 2022Device Damaged by Another Device; Device Damaged by Another Device
A PURCHASING AGENT REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS SCRATCHED WHILE ADVANCING THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 14548856 ↗
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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