ACRYSOF® ACRYSERT® SN6CWS (REF SN6CWS.215)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ ASPHERIC IOL, SP ACRYLIC FOLDABLELENS, w/AcrySert(R) DELIVERY SYSTEM, UV w/BLUELIGHT FILTER, 13.0mm LENGTH, 6.0mm ANTERIORASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. · Class 3 · Implant
Data updated Oct 18, 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 00380652249249), received between Sep 30, 2022 and May 15, 2025 — classified as 1 injury, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance2
- Device Damaged by Another Device1
- Physical Resistance/Sticking1
Patient problems
- Blurred Vision1
- Capsular Bag Tear1
- 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 15, 2025Failure to Advance; Failure to Advance
A CASE WAS RECEIVED FROM CHINA HA SYSTEM THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER COULDN'T PUSH NORMALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22028131 ↗InjuryDec 21, 2022Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
A HEALTH AUTHORITY REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DID NOT PUSH SMOOTHLY AND SUDDENLY THE RESISTANCE HAD INCREASED. CAUSING THE INJECTOR HEAD TO PUNCTURE THE POSTERIOR CAPSULE. WHICH CAUSED THE PROLONGED HOSPITALIZATION, POOR CRYSTAL STABILITY, AND BLURRED VISION OF PATIENTS.
Patient problems: Blurred Vision; Capsular Bag Tear
MAUDE report 16023723 ↗MalfunctionSep 30, 2022Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), A SCRATCH ON IOL OPTIC WAS NOTED. THE LENS WAS THEN REMOVED IMMEDIATELY AND THE SURGERY WAS COMPLETED USING A BACK UP LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15519007 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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