TECNIS IOL DIU600 (REF DIU600U215)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 21.5D CYL6.00 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474750111), received between Aug 20, 2024 and Jan 3, 2025 — classified as 2 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Visual Impairment2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A HYPEROPIC SURPRISE, SPECIFICALLY A +1.50 SPHERICAL EQUIVALENT IN THE LEFT EYE, ONE WEEK AFTER INTRAOCULAR LENS (IOL) IMPLANTATION. THE PATIENT THEN WAS SCHEDULED FOR AN EXPLANT ON (B)(6) 2024. EXPLANT WAS DONE AS SCHEDULED, THE DOCTOR USED IRIS HOOKS AND SUTURES, NO VITRECTOMY. IT WAS NOTED THAT THE PATIENT HAS A PREEXISTING CONDITION OF FLOPPY IRIS SYNDROME, HENCE THE IRIS HOOKS WERE USED. REPLACEMENT IOL WAS SAME MODEL BUT 3.5D POWER SIZE HIGHER AS THE ORIGINAL IOL. IT WAS UNKNOWN IF REPLACEMENT IOL HELPED ADDRESS THE VISUAL ISSUES OF THE PATIENT. NEVERTHELESS, THERE WAS NO INJURY, AND SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 21072400 ↗InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCE REFRACTIVE ERRORS AFTER IMPLANT OF A PRELOADED INTRAOCULAR LENS (IOL). THE LENS WAS EXPLANTED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 20003540 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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