TECNIS IOL DFW375 (REF DFW375U215)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 21.5D CYL3.75 · Class 3 · Implant
Data updated Oct 13, 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 05050474753068), received between Sep 27, 2021 and Jan 28, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision2
- Visual Disturbances2
- Foreign Body Sensation in Eye1
- Halo1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE DUE TO BLURRY VISION, HALOS, DIFFICULTIES WITH NIGHT DRIVING, AND DEPTH PERCEPTION. NO ANTERIOR VITRECTOMY, NO EXTENDED INCISION, NO SUTURES AND NO DELAY IN PROCEDURE REPORTED. IT WAS CONFIRMED THAT THE LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 21261112 ↗InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE OF A PATIENT IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT¿S COMPLAINT OF BLURRY VISION. THE PATIENT WAS UNCOMFORTABLE AND WANTED THE LENS OUT AS SOON AS POSSIBLE. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA): 20/40 ( ISOLATED LETTERS ONLY), UNCORRECTED BINOCULAR VISUAL ACUITY (UCNVA)- J8 @16-18INXHES UNCORRECTED INTERMEDIATE VISUAL ACUITY (UCIVA)- 20/60, MEDIAL RECTUS (M.R.): +.75-.75 @115, PINHOLE- NO IMPROVEMENT MACULAR OPTICAL COHERENCE TOMOGRAPHY (OCT)- CLEAR. NO VITRECTOMY, NO INCISION ENLARGEMENT AND /OR NO SUTURES WERE REQUIRED. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (22.0) DIOPTER WAS USED. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Visual Disturbances
MAUDE report 12531190 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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