TECNIS IOL DFW225 (REF DFW225U135)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 13.5D CYL2.25 · 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 05050474751729), received between Nov 11, 2021 and Dec 1, 2021 — 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. 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 Problem2
Patient problems
- Blurred Vision1
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENTS RIGHT EYE, ONE WEEK POST-OPERATIVE (OP), THE PATIENT WAS NOT HAPPY WITH HER VISION AND COMPLAINED OF BLURRY VISION. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON ZCU225 LENS (DIFFERENT MODEL AND HIGHER DIOPTER). THERE WAS NO PATIENT INJURY SUCH AS CAPSULE TEAR. REPORTEDLY, THE PATIENT IS DOING WELL. NO ONE ELSE CAN PROVIDE ANY FURTHER INFORMATION, THAT IS ALL THE INFORMATION THEY HAVE.
Patient problems: Blurred Vision
MAUDE report 12910343 ↗InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE DUE TO COMPLAINTS OF INTOLERANCE DUE TO SECONDARY GLARE. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED STATING THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION IOL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; Visual Disturbances
MAUDE report 12800850 ↗
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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