TECNIS IOL DFR00V (REF DFR00VU070)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY SIMPLICITY 07.0D · 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 05050474750418), received between Mar 29, 2023 and Mar 13, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision2
- Discomfort1
- Halo1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DFR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OPERATIVE EYE. DUE TO COMPLAINTS OF DISSATISFACTION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 IOL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Discomfort
MAUDE report 18891998 ↗InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DFR00V INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF MECHANICAL FAILURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS, DIOPTER SIZE UNKNOWN. IOL MECHANICAL FAILURE WAS CLARIFIED AS REPORT OF CONSTANT BLURRED VISION AND CONSTANT HALOS AROUND LIGHTS. IN ADDITION, THE PATIENT DID NOT FEEL SAFE DRIVING AT NIGHT DUE TO BLURRED VISION AND CONSTANT HALOS. THERE WAS NO PATIENT INJURY AND NO SUTURE(S) HOWEVER, THE INCISION WAS ENLARGED AND A PLANNED VITRECTOMY WAS PERFORMED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS PATIENT HAPPY WITH VISION, OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Halo
MAUDE report 16640892 ↗
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