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TECNIS IOL DIU375 (REF DIU375U325)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 32.5D CYL3.75 · Class 3 · Implant

All models of TECNIS IOL (1344)

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 05050474748569), received between May 26, 2022 and May 26, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Blurred Vision1
  • Visual Impairment1

Recent adverse event reports

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

  • InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED PATIENT COMPLAINED ABOUT HER VISION STAYING BLURRY AND THE SURGEON CALLED IT MYOPIC SURPRISE. THEREFORE, THE LENS WAS EXPLANTED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE IOL HAS BEEN DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Blurred Vision; Visual Impairment

    MAUDE report 14519054 ↗

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Sources and updates

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