ACRYSOF® SA60AT (REF SA60AT.150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652555708), received between Nov 24, 2022 and Jan 3, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Material Opacification; Material Opacification

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE CONTROL AFTER 24 HOURS OF THE IMPLANTATION, THE SURGEON NOTICED THAT THE IOL WAS COMPLETELY OPACIFIED. THE LENS EXPLANTATION WAS PLANNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21067089 ↗
• MalfunctionJan 15, 2023Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED ABOUT AN UNSPECIFIED DEFECTIVE LENS.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16171661 ↗
• InjuryNov 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SERIOUS INFECTION WAS CAUSED IMMEDIATELY AFTER SURGERY AFTER INSERTION OF THE INTRA OCULAR LENS, THE IOL WAS REMOVED IN A SECONDARY PROCEDURE AND THERE IS NO VISION DUE TO SEVERE HARM TO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THE EYE WAS COMPLETELY BLOODY LIKE A GLOBAL RUPTURE HAS HAPPENED AND THE IRIS WAS WHITE-GREENISH WHICH SHOWS CLEAR INFECTION. ON THE DAY OF SURGERY AND NEXT DAY, THE SYMPTOMS PERSISTED AND HIS VISION WAS VERY CLOUDY, THE AMOUNT OF WHITE-GREENISH COLOR ON THE CORNEA WAS INCREASED WITH EXTREME PAIN. ON THIRD DAY HE LOST HIS VISION AND CAN'T SEE ANYTHING, WITH VERY EXTREME PAIN AND EYE INCREASED SWELLING, HIGH BLOOD PRESSURE AND SUGAR LEVELS. ON FOURTH DAY THE EYE WAS VERY SWOLLEN CAN'T OPEN IT AT ALL, AND FULL OF PUSS WITH RAISE IN TEMPERATURE AND DETERIORATED SYMPTOMS. AFTER THE OPERATION THE PATIENT EYE WAS MORE SWOLLEN AND RED COLOR AND SYMPTOMS INCREASING. AFTER A DAY HE LOST VISION AND CAN'T SEE ANYTHING, WITH A MORE SWOLLEN EYE AND OTHER SYSTEMATIC SYMPTOMS, THEN A LOT OF PUSS AND INFLAMMATION SHOWED

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Clouding/Hazing; Endophthalmitis; Eye Injury; Eye Pain; Fever; High Blood Pressure/ Hypertension; Inflammation; Red Eye(s); Rupture; Swelling/ Edema; Visual Impairment; Vitreous Floaters

  MAUDE report 15861563 ↗