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TECNIS IOL DIU300 (REF DIU300U180)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 18.0D 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474747685), received between Jan 20, 2022 and Jan 20, 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

  • Capsular Bag Tear1

Recent adverse event reports

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

  • InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS WAS REMOVED FROM THE PATIENT'S RIGHT EYE AS HE DID NOT HAVE ENOUGH CAPSULAR SUPPORT TO HOLD THE LENS. IT WAS STATED THAT THE PATIENT MOST LIKELY HAD SMALL POSTERIOR CAPSULE TEAR DURING THE INITIAL IMPLANTATION THAT WAS NOT APPARENT, HOWEVER, IT WAS ONLY APPARENT WHEN THE SURGEON ATTEMPTED THE LENS EXCHANGE. A COMPETITOR 3 PIECE LENS WAS USED AS THE REPLACEMENT AND THE ENLARGED CORNEAL WOUND WAS SUTURED TO ACCOMMODATE THE LENS EXCHANGE PROCEDURE, WHICH WAS STATED TO BE A STANDARD OF CARE. THERE WAS NO OTHER PATIENT INJURY REPORTED. THE PATIENT WAS DOING WELL POST OPERATION WITH 20/40 VISION UNCORRECTED, WHICH WOULD BE IMPROVING WITH REFRACTION BY OPTOMETRY. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Capsular Bag Tear

    MAUDE report 13310507 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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