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TECNIS IOL DIU300 (REF DIU300U250)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 25.0D CYL3.00 · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474747821), received between Jul 23, 2024 and Jul 23, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Unstable1

Patient problems

  • Swelling/ Edema1

Recent adverse event reports

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

  • MalfunctionJul 23, 2024Unstable; Unstable

    IT WAS REPORTED THAT THE FULLY IMPLANTED PRELOADED TORIC INTRAOCULAR LENS (IOL) HAD AN APPROXIMATELY 40 DEGREE TORIC ROTATION IN THE LEFT EYE DUE TO RETINAL SWELLING. THE SURGEON PLANS TO LEAVE IT ALONE DUE TO PATIENT RISK. THE ISSUE WAS NOT DUE TO A MALFUNCTION OR DEFECT OF THE LENS. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND NO INTERVENTIONS ARE PLANNED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Swelling/ Edema

    MAUDE report 19807701 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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