ACRYSOF® SA60WF (REF SA60WF.295)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652332859), received between Jun 23, 2023 and Sep 8, 2023 — classified as 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
- Scratched Material1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2023Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THAT THERE WAS CRACK ON THE LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE SURGEON DID NOT REMOVE THE LENS FROM THE EYE AS THE CRACK WAS NOT IN THE VISUAL PLANE.
Patient problems: Insufficient Information
MAUDE report 17712649 ↗MalfunctionJun 23, 2023Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT LENS BODY HAS A DEEP CREVICE/SCRATCH NEAR THE MIDDLE. SURGEON WAS ABLE TO REMOVE THE DEFECTIVE LENS SAFELY. MEDICAL INTERVENTION WAS REQUIRED FOR CUTTING THE LENS IN HALF TO REMOVE IT FROM THE EYE IMMEDIATELY AFTER IMPLANTING. THE PROCEDURE WAS COMPLETED WITH THE BACKUP LENS ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 17190171 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page