TECNIS IOL DFW225 (REF DFW225U180)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 18.0D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751811), received between Mar 25, 2022 and May 13, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Failure to Fold1
Patient problems
- Flashers1
- Halo1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2022Break; Failure to Fold; Break; Failure to Fold
IT WAS REPORTED TODAY DURING HIS INTRAOCULAR LENS (IOL) IMPLANT CASE, THE LEAD HAPTIC WAS PROTRUDING OUT OF THE SIMPLICITY INSERTER PRIOR TO IMPLANT. THE DOCTOR TRIED TO TUCK THE LEAD HAPTIC BACK INTO THE TIP AND IMPLANT THE IOL INTO EYE. ONCE IN PATIENT¿S EYE, THE HAPTIC WAS "TWISTED." HE WAS ABLE TO MANIPULATE THE HAPTIC INTO THE CORRECT POSITION AND LEAVE THE IOL INSERTED IN THE PATIENT¿S EYE. NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14402619 ↗InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE DUE TO COMPLAINTS OF GLARE/HALOS AND BEAMS/RODS OF LIGHT AT NIGHT AND REPLACED WITH A DIFFERENT MODEL LENS WITH A DIFFERENT DIOPTER SIZE, DIU225 18.5 DIOPTER IOL. THERE WAS NO COMPLICATIONS AND NO VITRECTOMY. PATIENT OUTCOME POST LENS EXCHANGE WAS REPORTED AS: 1-DAY POST-OP STABLE, PATIENT RETURNING IN THREE (03) WEEKS FOR POST OPERATIVE REFRACTION/CHECKUP. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Flashers; Halo; Visual Disturbances
MAUDE report 13897301 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page