TECNIS IOL DFR00V (REF DFR00VU255)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY SIMPLICITY 25.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474750784), received between Nov 30, 2021 and Oct 17, 2024 — classified as 3 injuries, 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Break1
Patient problems
- Halo2
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2024Break; Break
IT WAS REPORTED THAT THE HAPTIC OF PRELOADED INTRAOCULAR LENS (IOL) WAS TORN/BROKEN. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20476875 ↗InjuryOct 26, 2022Adverse 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 RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO MULTIFOCAL REFRACTIVE SURPRISE. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 15677649 ↗InjuryFeb 10, 2022Adverse 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 DUE TO HALO AND GLARE. THAT AT 1-MONTH POST-OP EXAMINATION, THE PATIENT ENDED UP BOTH EYES (OU) 20/20 J1, BUT COULD NOT TOLERATE HALO/GLARE. THE LENS WAS REMOVED AND REPLACED WITH A NON-JOHNSON AND JOHNSON MONOFOCAL IOL. THE LENS WAS DISCARDED, AND NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 13503585 ↗InjuryNov 30, 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 A PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE AS THE PATIENT COMPLAINED ABOUT HALOS AND WAS NOT ADAPTING AFTER SIX (6) WEEKS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON-JOHNSON & JOHNSON (J&J) LENS AS A REPLACEMENT. THERE WAS NO DAMAGE TO THE CAPSULE OR ANY COMPLICATIONS DURING THE SURGERY AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE EXPLANTED LENS WAS DISCARDED. IT WAS INDICATED THAT THIS WAS THE PATIENT¿S SECOND EYE AND THEY HAD A NON-J&J LENS IN THE FIRST EYE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo
MAUDE report 12905937 ↗
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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