TECNIS IOL DIU300 (REF DIU300U085)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 08.5D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474747494), received between Jun 27, 2022 and Jul 21, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A TORIC INTRAOCULAR LENS (IOL). FOLLOWING THE PROCEDURE, CAPSULE ISSUES WERE OBSERVED, AND THE LENS WAS FOUND TO BE MISALIGNED. THE PATIENT WAS REFERRED TO A CORNEA SPECIALIST. THE DOCTOR EXPLANTED THE LENS IN A SECONDARY SURGICAL PROCEDURE AND PLACED A NON-JOHNSON & JOHNSON IOL IN SULCUS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear
MAUDE report 22555901 ↗InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) SPHERICAL EQUIVALENT (SE) AIM WAS EMMETROPIA WHEN TARGET WAS RESIDUAL MYOPIA. REPORT RECEIVED ON MAR(B)(6) CH 14, 2022, FROM A HEALTH CARE PROVIDER INDICATING THEY PLANED ON EXPLANTING THE J&J IOL FROM THE PATIENT¿S LEFT EYE. THE ISSUE WAS NOTED ONE-WEEK POST-OPERATIVE (OP). FOLLOW-UP WAS DONE TO CONFIRM IF THE IOL WAS EXPLANTED, BUT THE CUSTOMER DID NOT RESPOND. UPON COMPLETING THE PRODUCT INVESTIGATION JUNE 6 2022, IT WAS NOTED THAT THE IOL HAD BEEN RETURNED AND THEREFORE EXPLANTED. FOLLOW-UP TO CONFIRM THE EXPLANT DATE WAS DONE AGAIN, BUT THE CUSTOMER DID NOT RESPOND. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 14837805 ↗
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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