ACRYSOF® SN6AT5 (REF SN6AT5.185)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652250962), received between Sep 13, 2024 and Sep 13, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Discolored” (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.
Reports received per month
Most reported problems
Device problems
- Material Discolored1
Patient problems
- Posterior Capsule Opacification1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2024Material Discolored; Material Discolored
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED SEVERE POSTERIOR CAPSULAR OPACIFICATION AND HAD A YAG LASER TREATMENT BEFORE TO REMOVE PCO. PATIENT HAS DEVELOPED CANCER AND IS ALSO NOW ON CANCER TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THE PATIENT¿S VISION WAS GOOD, CORRECTED TO 1.2 IN RIGHT EYE. IN 2017, NOTICED THE GRADUAL ONSET SYMPTOMS OF PCO. AFTER YAG LASER TREATMENT, VISION WAS IMPROVED FROM 0.8 TO 1.0 IN THE LEFT EYE, VISION CLEARED UP AND WAS GOOD. IN 2019 DURING EXAMINATION OF PCO RECURRENCE THEY NOTICED SLIGHT YELLOWING OF IOL, POSSIBLE OPACIFICATION STARTING. IN 2022, ALSO HAD A SAME FINDING. SO, THEY HAVE PLANNED A SURGERY FOR THE PATIENT.
Patient problems: Posterior Capsule Opacification
MAUDE report 20214027 ↗
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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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