TECNIS IOL DIU375 (REF DIU375U165)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 16.5D 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 05050474748248), received between Sep 12, 2022 and Sep 12, 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.
InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO PLACE THE INTRAOCULAR LENS (IOL) AND IT WAS "A CAPSULE RUPTURE WITH LENS INJECTION." THE SURGEON ENDED UP IMPLANTING ANOTHER JOHNSON & JOHNSON IOL (DIFFERENT MODEL, ZA9003, DIFFERENT DIOPTER OF 15.0) AS REPLACEMENT. THE DEVICE HAS BEEN DISCARDED. THROUGH FOLLOW-UP IT WAS LEARNED THAT THERE WAS NO ISSUE NOTED WITH THE IOL ITSELF. THE PATIENT DID NOT HAVE ANY PRE-EXISTING DIAGNOSIS THAT WOULD HAVE CONTRIBUTED TO THE CAPSULE RUPTURE. IT WAS CONFIRMED THAT THE CAPSULE RUPTURED WHEN THE LENS WAS INSERTED IN THE RIGHT EYE. NO SUTURES, VITRECTOMY, INCISION ENLARGEMENT, OR ANY OTHER SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS HAPPY, HAS NO ISSUES, AND IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 15406991 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page