TECNIS IOL DFR00V (REF DFR00VU245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474750760), received between Nov 12, 2021 and Nov 9, 2023 — classified as 10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYNERGY SIMPLICITY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DURING SECONDARY SURGERY DUE TO THE PATIENT WAS SUFFERING FROM BLURRY VISION AT ALL RANGES, CAN¿T SEE STREET SIGNS. THERE WAS NO INFORMATION ABOUT INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THE LENS WAS REPLACED WITH ANOTHER J&J DIFFERENT MODEL, BUT WITH THE SAME DIOPTER. THE PATIENT'S POST-PROCEDURE STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 18104118 ↗
• InjuryOct 29, 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 THE PATIENT'S LEFT EYE (OS) DUE TO THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA. ANOTHER JOHNSON & JOHNSON LENS, MODEL DFR00V 24.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THERE WAS NO REPORTED PATIENT INJURY AND PATIENT IS STATED TO BE FULLY RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15695115 ↗
• InjurySep 19, 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 THE PATIENT'S RIGHT EYE DUE TO PATIENT NOT HAPPY WITH QUALITY OF VISION (HALOS) AND WANTED THE IOL REMOVED. IT WAS STATED THAT REPLACEMENT LENS WAS ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00, 24.5D. NO ADVERSE EVENTS, NO PATIENT POST-EXPLANT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 15452294 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING OCULAR DISCOMFORT AND GLARE IN THEIR RIGHT EYE (OD) RESULTING IN THE NEED FOR AN EXPLANT OF THE INTRAOCULAR LENS (IOL). THE PATIENT WAS STATED TO BE UNABLE TO DRIVE AT NIGHT. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT IS DOING WELL AFTER EXPLANT. THE IOL WILL NOT BE RETURNED AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Pain; Visual Disturbances

  MAUDE report 15316390 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCED HORRIBLE POOR DISTANCE VISION AND RUINED ITS LIFE (PATIENT IS A PAINTER), THEREFORE, THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS). ANOTHER JOHNSON & JOHNSON LENS, MODEL AR40E 24.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Blurred Vision

  MAUDE report 15254985 ↗
• InjuryJun 30, 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. THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 14881877 ↗
• InjuryJun 17, 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 IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE FOR UNKNOWN REASONS AND REPLACED WITH ANOTHER JOHNSON & JOHNSON DFR00V IOL WITH UNKNOWN DIOPTER SIZE. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 14739634 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED GLARE AND HALOS WITH DIFFICULTY DRIVING AT NIGHT POST INTRAOCULAR LENS (IOL) IMPLANTATION IN THEIR RIGHT EYE. THE DOCTOR EXPLANTED THE IOL OVER 3 MONTHS POST IOL IMPLANTATION. A NON JOHNSON AND JOHNSON IOL WAS PLACED AS THE REPLACEMENT LENS. THE EXPLANTED IOL WAS DISCARDED. THERE WAS NO REPORT OF ANY OTHER ADVERSE EVENTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14439950 ↗
• InjuryDec 3, 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 LEFT EYE DUE TO VISUAL SUBJECTIVE DISTURBANCE. THE EXPLANTED LENS WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. PATIENT DOING FINE POST-EXCHANGE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 12930179 ↗
• InjuryNov 12, 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 BECAUSE OF HYPEROPIC MISS, THE PATIENT CANNOT TOLERATE MULTIFOCAL LENS. THIS WAS NOTICED A FEW WEEKS POST-IMPLANT. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER, 25.5D, SERIAL NUMBER (B)(4) WAS USED. NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE REQUIRED. NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12808001 ↗