TECNIS IOL DFR00V (REF DFR00VU260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474750791), received between Nov 8, 2021 and Oct 2, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A CRACK IN THE OPTIC OF THE LENS. BALANCED SALT SOLUTION (BSS) AT ROOM TEMPERATURE WITH ADDITIVES (OMIDRIA) WAS USED AS CARTRIDGE LUBRICANT. THE LENS WAS FULLY INSERTED IN THE LEFT EYE AND THEN REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL AND DIOPTER) IN THE SAME PROCEDURE. AN INCISION ENLARGEMENT WAS REQUIRED. THERE WAS NO PATIENT INJURY. THERE WAS CORNEA EDEMA THAT LASTED ONE WEEK AND NO MEDICATION WAS PRESCRIBED. THE EDEMA RESOLVED. PER THE PATIENT, THE VISION IS GREAT POST-OPERATIVELY. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema

  MAUDE report 17857032 ↗
• InjuryJun 9, 2023Adverse 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 INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF EXTREME NIGHT TIME GLARE. THE IOL WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 26.0 DIOPTER IOL. THERE WERE NO COMPLICATIONS OR INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS DOING FINE AND VERY SATISFIED. THE EXPLANTED LENS IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17101577 ↗
• InjuryApr 6, 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 LEFT EYE IN A SECONDARY SURGICAL PROCEDURE AS THE PATIENT FELT THAT THEIR VISION WAS BLURRY ALL THE TIME. TH PATIENT HAD DIFFICULTY WITH DISTANCE VISION AND DRIVING AT NIGHT. THE PATIENT DID NOT LIKE THE QUALITY OF THEIR VISION WITH THE SYNERGY LENS, WAS UNHAPPY, AND REPORTEDLY WOULD NOT BE SATISFIED WITH THEIR VISION EVEN IF THEY ARE PLANO REFRACTION. A NON-JOHNSON AND JOHNSON LENS OF 26.0 DIOPTER WAS USED AS THE REPLACEMENT. NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME WAS REPORTED TO BE GOOD; PATIENT IS HAPPY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14018794 ↗
• MalfunctionNov 8, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED DURING PRODUCT HANDLING AND PRIOR TO INSERTION THE PRE-LOADED INTRAOCULAR LENS (IOL), THE LENS WAS STUCK IN THE CARTRIDGE AND HAPTIC WAS GETTING CRUSHED; THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS AND/OR HAPTICS WAS DAMAGED IN THE PRE-LOADED DEVICE PRIOR TO PATIENT CONTACT AND THE SAME MODEL AND DIOPTER BACKUP LENS WAS USED WITH NO ISSUES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12776052 ↗