TECNIS IOL DFR00V (REF DFR00VU140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474750555), received between Feb 11, 2022 and Mar 19, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO MECHANICAL FAILURE. THERE WAS INCISION ENLARGEMENT TO REMOVE THE LENS IN WHOLE. HOWEVER, NO VITRECTOMY OR SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18937810 ↗
• InjuryJun 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO DISLOCATION, HALOS, AND BALANCE ISSUES. THE PATIENT DID NOT HAVE A DEBILITATING CONDITION DUE TO THESE ISSUES. THE PATIENT DOES NOT HAVE ANY PRE-EXISTING MEDICAL HISTORY ISSUES. A NON-JOHNSON AND JOHNSON LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED (SAME DIOPTER). NO ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT IS ¿OK¿ POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Insufficient Information

  MAUDE report 17136131 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING EXCESSIVE GLARE IN THEIR LEFT EYE (OS) RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). THE VISUAL ISSUES AFFECTED PATIENT'S NORMAL DAILY ACTIVITIES AND WERE DEBILITATING. THE PATIENT'S PRE-OPERATION VISUAL ACUITY WAS 20/70, THE INTENDED/TARGETED POST-OPERATIVE REFRACTION WAS PLANO AND POST-OPERATION VISUAL ACUITY WAS 20/100. THE IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON LENS OF 13.5 DIOPTER. NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE PATIENT IS STATED TO HAVE TOLERATED THE PROCEDURE WELL AND IS EXPECTED TO MAKE A FULL RECOVERY. THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE IOL WILL NOT BE RETURNED FOR INVESTIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15578478 ↗
• InjuryAug 10, 2022Adverse 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. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15204657 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH THE INTRAOCULAR LENS (IOL) IMPLANTED IN BOTH EYES. THE PATIENT HAD ¿TROUBLE¿ UPON WAKING UP FROM SURGERY AND WAS UNABLE TO ¿SEE MUCH ON ANYTHING AT FIRST WITH THE 1ST LENS EVERYTHING HAD AN EXTENSION TO THE BORDER AND VERY BLURRY.¿ THE PATIENT WAS UNABLE TO SEE FAR AWAY AND HAD TO WEAR GLASSES. THE PATIENT REPORTED THAT THE DOCTOR ADVISED THAT THE PATIENT'S BRAIN WAS NOT ADAPTING TO THE LENSES. AFTER A MONTH, THE PATIENT WAS ABLE TO SEE MID-RANGE AND CLOSE UP ENOUGH TO READ, BUT STILL DIFFICULTY WITH DISTANCE. THE PATIENT HAD AN IOL EXCHANGE IN BOTH EYES. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (LEFT EYE/OS: DIFFERENT MODEL, DIU150, DIFFERENT DIOPTER OF 14.5, CYLINDER 1.50; RIGHT EYE/OD: DIFFERENT MODEL, DIU150, SAME DIOPTER, CYLINDER 1.50). THE PATIENT REPORTED THAT THE LENS EXCHANGE SURGERY WAS "HORRIFIC," AS THE LENS HAD TO BE CUT IN HALF IN THE EYE IN ORDER TO BE REMOVED AND THE PATIENT CAN NOW SEE A BULGE/CUT ON EYE WHICH THE PATIENT'S THINKS IS SCAR TISSUE FROM THE INCISION ON THE "OUTER SIDE." NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP WITH THE DOCTOR, IT WAS LEARNED THAT THE PATIENT HAD 20/20 V

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 14002831 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ENDED UP OU 20/20 J1, BUT COULD NOT TOLERATE GLARE AND HALO AFTER THE IMPLANTATION OF THE SYNERGY INTRAOCULAR LENSES (IOLS) IN BOTH EYES (OU). THE LENSES WERE REMOVED AND REPLACED WITH NON-JOHNSON AND JOHNSON MONOFOCAL LENSES AFTER THE 1-MONTH POST-OP APPOINTMENT. THE EXPLANTED IOLS WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT REPRESENTS THE LEFT (OS) EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT (OD) EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13511721 ↗