ACRYSOF® IQ RESTOR® SN6AD1 (UDI 00380652241625)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652241625), received between Nov 19, 2021 and Nov 19, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED BLURRY VISION AT INTERMEDIATE AND DISTANCE AND DELAY IN FOCUSING FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT. THE CONSUMER ALSO REPORTED THAT HE HAD POSTERIOR CAPSULE OPACIFICATION IN THIS EYE AND HIS DOCTOR PERFORMED A YAG LASER. SIX YEARS LATER, THE PATIENT IS REPORTING THAT HIS VISION IS WORSE AND HE CANNOT READ. ADDITIONAL INFORMATION WAS PROVIDED BY THE CONSUMER THAT HE SAW BLACK ARTICLES FLOATING AROUND THE IOL IN A VIDEO HIS SURGEON PROVIDED. HE ALSO REPORTED THAT HE CANNOT DRIVE AT NIGHT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Vitreous Floaters

  MAUDE report 12846852 ↗