TECNIS IOL DIU300 (REF DIU300U165)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 16.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474747654), received between Apr 13, 2023 and Feb 12, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS EXPLANTED DUE TO THE REFRACTIVE SURPRISE. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER, A J&J IOL. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 21370467 ↗MalfunctionApr 13, 2023Crack; Mechanical Jam; Crack; Mechanical Jam
IT WAS REPORTED THAT A PRELOADED PRODUCT TIP OF CARTRIDGE CRACKED AND THE INTRAOCULAR LENS (IOL) GOT STUCK IN INJECTOR, UNKNOWN IF WITH PATIENT CONTACT OR NOT. IT WAS STATED THAT CUSTOMER IMPLANTED ANOTHER IOL. NO ISSUE WITH PATIENT. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16735185 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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