TECNIS IOL DIU150 (REF DIU150U165)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC EYHANCE TOR II SMPLCTY 16.5D CYL1.50 · Class 3 · Implant
- 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 05050474746473), received between Feb 3, 2022 and Mar 10, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Scratched Material1
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.
InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTING AN INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, THEIR DISTANCE VISION WAS NOT OPTIMIZED, NOT SHARP. THE LEFT WAS MONOVISION FOR DISTANCE, HAD RESIDUAL HYPEROPIA AND ASTIGMATISM. REPORTEDLY, IN NOVEMBER, THE PATIENT¿S VISION WAS NOT OPTIMAL. THE IOL WAS EXPLANTED (B)(6) 2022. THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REQUIRED. PRE-OPERATIVE VISUAL ACUITY 20/40 AND POST OPERATIVE VISUAL ACUITY IS 20/25- 20/30. THE IOL EXCHANGE WAS SUCCESSFUL AS THE FINAL OUTCOME IMPROVED FOLLOWING THE IOL EXPLANT. ON (B)(6) 2022, THE PATIENT¿S VISUAL ACUITY WAS 20/25 SC (WITHOUT CORRECTION) AND BEST CORRECTED 20/20-. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 13727394 ↗MalfunctionFeb 3, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE SURGEON OBSERVED SCRATCHES ON THE TECNIS EYHANCE INTRAOCULAR LENS (IOL) DURING IMPLANTATION. THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS DURING THE SAME PROCEDURE. THE PATIENT OUTCOME WAS NOT PROVIDED. THE CUSTOMER INDICATED THAT THE LENS WAS DISCARDED AFTER THE REPLACEMENT WAS COMPLETED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, A DEFINITIVE RESPONSE HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446825 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.