ACRYSOF® SA60WF (REF SA60WF.160)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) ASPHERIC IOL, SINGLE-PIECE ACRYLICFOLDABLE POSTERIOR CHAMBER LENS,UV-ABSORBING, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652332583), received between Apr 22, 2022 and Jul 5, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Scratched Material1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2022Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FACILITY REPRESENTATIVE REPORTED A MARK ON IOL AT THE BASE OF HAPTIC NOTED AFTER INSERTION, LENS WAS REMOVED AND REPLACED WITH ANOTHER IOL, OF SAME MODEL AND SAME DIOPTER. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14914021 ↗InjuryApr 22, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS FOUND A STRING ON THE THREE LENSES. THE FACILITY HAS COLLECTED THE ONE STRING IN A JAR. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE DAMAGED OPTIC WAS FOUND DURING PLACEMENT OF LENS AND LATER IT TURNS OUT TO BE A STRING WHICH COULD NOT BE REMOVED FROM THE OPTICS DURING INITIAL PROCEDURE. THE STRING WAS SCRAPED OFF THE OPTIC WITH A SWEEP. THE DEVICE CAME TO CONTACT WITH THE PATIENT. THE SURGERY DELAYED BY MORE THAN 1 HOUR, HOWEVER, THE PROCEDURE WAS COMPLETED WITH THE BACK UP LENS. THERE WAS NO NEGATIVE CONSEQUENCES OCCURRED TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND THE WOUND WAS ENLARGED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, THE PATIENT HAD SUTURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14185718 ↗
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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