TECNIS IOL DFW375 (REF DFW375U190)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 19.0D 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 05050474753013), received between Nov 10, 2022 and Nov 10, 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
- Blurred Vision1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT COULD NOT TOLERATE THE SYNERGY INTRAOCULAR LENS (IOL) AND WAS EXPERIENCING BLURRY VISION AND VISUAL DISTURBANCES IN THE LEFT EYE (OS). IT COULD NOT BE CORRECTED BY GLASSES. THEREFORE, THE LENS WAS EXPLANTED. THE PATIENT'S PRE-OPERATION BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20. THE PATIENT'S UNCORRECTED VISUAL ACUITY POST-OPERATION WAS 20/30 AND BCVA 20/25. THE INTENDED POST-OPERATIVE REFRACTION WAS 20/20. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIU375 18.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE PATIENT CONTINUES TO BE UNSATISFIED WITH VISION FOLLOWING SURGERY AS HER VISION IS STILL BLURRY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 15777152 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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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