TECNIS IOL DFR00V (REF DFR00VU265)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY SIMPLICITY 26.5D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474750807), received between Oct 22, 2021 and May 9, 2023 — classified as 1 injury, 2 malfunctions.
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
- Device Difficult to Setup or Prepare1
- Material Fragmentation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2023Break; Mechanical Problem; Device Difficult to Setup or Prepare; Break; Mechanical Problem; Device Difficult to Setup or Prepare
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IS TOO STIFF TO IMPLANT. THE PLUNGER MISSED LENS. NO PATIENT CONTACT. THE PATIENT IS FINE POST-OP. THE PROCEDURE WAS COMPLETED WITH THE BACK-UP IOL. NO OTHER INFORMATION IS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16899258 ↗MalfunctionOct 30, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT PRIOR TO INSERTION, THE TRAILING HAPTIC OF THE PRE-LOADED DFR00V INTRAOCULAR LENS (IOL) BROKE OFF AND THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15697727 ↗InjuryOct 22, 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 PATIENT'S RIGHT EYE DUE TO HALOS/GLARE AND UNEXPECTED POST-OPERATIVE (OP) AT 1 WEEK POST-OP. THE PATIENT WAS UNABLE TO SEE OBJECTS CLEARLY. VISUAL ACUITY WAS NOT CLEAR LIKE LOOKING THROUGH OIL. A NON-JOHNSON AND JOHNSON IOL WAS USED AS REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances; Visual Impairment
MAUDE report 12684685 ↗
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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