ACRYSOF® SN60AT (REF SN60AT.310)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) Natural SINGLE-PIECE ACRYLICFOLDABLE IOL, UV WITH BLUE LIGHT FILTER,POSTERIOR CHAMBER LENS (IOL/PC), 13.0mm LENGTH,6.0mm BICONVEX OPTIC, PLANAR HAPTICS. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380650130518), received between Jun 15, 2021 and May 31, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
- Defective Device1
- Inaccurate Delivery1
Patient problems
- Capsular Bag Tear1
- Eye Injury1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 31, 2022Crack; Crack
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMPLANT INJECTED IN PATIENT'S EYE WITH COMPANY INJECTOR AND COMPANY CARTRIDGE BUT SEEMS TO BE CRACKED IN CENTER AFTER UNSUCCESSFUL ATTEMPTS WITH COMPANY CARTRIDGES OTHER. THE PHYSICIAN DID NOT WANT TO EXPLANT IMPLANT BECAUSE HE FOUND THE IMPLANT TOO RIGID. ADDITIONAL INFORMATION WAS RECEIVED FROM INITIAL REPORTER STATING CATARACT SURGICAL PROCEDURE WAS BEING PERFORMED AT THE TIME OF THE EVENT.
Patient problems: Insufficient Information
MAUDE report 14546803 ↗InjuryOct 11, 2021Defective Device; Defective Device
A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS REMAINED RIGID AND PUNCTURED THE PATIENT ANTERIOR CHAMBER. THE SURGEON HAD TO CUT OUT THE LENS AND REPLACE WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED REPORTING THAT THE LENS WAS QUITE RIGID DURING IMPLANTATION, THERE WAS NO VITREOUS LEAK AND DID NOT REQUIRED ANY SUTURES BUT ENLARGED INCISION.
Patient problems: Capsular Bag Tear; Eye Injury
MAUDE report 12606129 ↗MalfunctionJun 15, 2021Inaccurate Delivery; Inaccurate Delivery
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WOULD NOT INSERT AND WOULD NOT SET AND HAD TO USE ANOTHER TO COMPLETE PROCEDURE. NO PATIENT HARM DOCUMENTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11997586 ↗
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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