TECNIS IOL DFW225 (REF DFW225U125)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 12.5D CYL2.25 · Class 3 · Implant
- 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 05050474751705), received between Jun 14, 2023 and Jun 14, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Bag Tear1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE SINCE THE PATIENT COULD NOT SEE NEAR OR DISTANCE GOOD ENOUGH. THE PATIENT DID NOT HAVE ANY PRE-EXISTING MEDICAL HISTORY ISSUES AND DID NOT HAVE DEBILITATING CONDITION. A NON-JOHNSON & JOHNSON LIGHT ADJUSTABLE LENS WAS USED AS A REPLACEMENT. IT WAS INDICATED THAT THERE WAS CAPSULE TEAR, AND AN UNPLANNED VITRECTOMY WAS PERFORMED. THERE WAS NO INCISION ENLARGEMENT. THE PATIENT OUTCOME WAS REPORTED TO BE OK. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE ISSUES REPORTED ON THE LENS IN PATIENT¿S LEFT EYE. A SEPARATE REPORT HAS ALREADY BEEN FILED FOR THE RIGHT EYE OF THE PATIENT.
Patient problems: Capsular Bag Tear; Visual Impairment
MAUDE report 17132220 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.