TECNIS IOL DFR00V (REF DFR00VU110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474750494), received between Feb 17, 2022 and Dec 22, 2023 — classified as 2 injuries, 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

Recent adverse event reports

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

• InjuryDec 22, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A MALE PATIENT REPORTED OF INTRAOCULAR LENS (IOL) EXPLANTS ON BOTH EYES (OU) DUE TO EXPERIENCING HALOS, GLARE AND PHYSICAL DISCOMFORT. PRIOR TO SURGERY, THE PATIENT HAD CATARACTS AND -600 VISION IN BOTH EYES. AFTER SURGERY THE PATIENT EXPERIENCED GLARES AND HALOS THAT IMPACTED HIS ABILITY TO DRIVE AND GO OUTSIDE. THE PATIENT STATED FOR NINE (9) MONTHS LIGHT MADE HIM CRY AND EVEN HAD TROUBLE WITH LIGHTS ON IN THE HOUSE. WHILE THE PATIENT HAD THE LENSES, HIS EYELIDS FELT LIKE MUSHY SPONGES AND WERE CONSTANTLY BLOODSHOT. THE PATIENT ATTRIBUTES THE ISSUE HE EXPERIENCED TO COATING AND THE DESIGN OF THE LENSES, COLLECTING TOO MUCH SUNLIGHT. THE PATIENT WAS TOLD HER WOULD SEE FROM "INFINITY TO 14 FEET" AND HE DID NOT WANT TO WEAR GLASSES ANYMORE AND TO BE ABLE TO READ THE PAPER. THE PATIENT SAW OTHER DOCTORS AND WAS ADVISED TO HAVE THEM REMOVED. THE LENSES WERE EXCHANGED, AND THE PATIENT HAS 20/20 VISION IN BOTH EYES WITH JOHNSON & JOHNSON MONOFOCAL REPLACEMENT LENSES. THE PATIENT STILL HAS TO WEAR GLASSES. A MONTH LATER 1.75 LEFT EYE, 2.0 RIGHT EYE. THE PATIENT IS DOING FINE WITH THE REPLACEMENT LENSES AND ONLY HAS SOME LEFTOVER CONDITIONS LIKE ITCHY EYES AND TEARS WHICH ARE DISSIPATING.

  Patient problems: Halo; Unspecified Tissue Injury; Visual Disturbances; Visual Impairment

  MAUDE report 18384368 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DFR00V MODEL 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 DYSPHOTOPSIA AND THE EXPLANTED IOL WAS REPLACED WITH A ZCB00 14.0 DIOPTER IOL FOR -1.75 TARGET. THERE WAS NO PATIENT INJURY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS STABLE POST-OP WITH SYMPTOMS RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Unspecified Tissue Injury; Visual Disturbances; Visual Impairment

  MAUDE report 18379566 ↗
• MalfunctionNov 2, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT UPON INJECTION OF THE INTRAOCULAR LENS (IOL) THERE WAS A SCRATCH THAT WAS MADE BY THE INJECTOR AS IT WAS PUSHING THE LENS INTO THE PATIENTS LEFT EYE. IT WAS CONFIRMED THAT THE LENS WAS FULLY INSERTED INTO THE PATIENTS EYE WHEN THE SCRATCH WAS NOTICED AND THAT THE TIP OF THE CARTRIDGE WAS NOT DAMAGED/BROKEN. THE LENS WAS CUT OUT AND REMOVED FROM THE EYE. A BACKUP LENS OF THE SAME MODEL AND DIOPTER WAS USED AS REPLACEMENT DURING THE SAME PROCEDURE. IT WAS INDICATED THAT BALANCED SALT SOLUTION (BSS) WAS USED. THE LENS WAS CONTINUALLY LUBRICATED UNTIL IT WAS HANDED TO THE SURGEON. THERE WERE NO SURGICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME IS UNKNOWN DUE TO HAVING POST-OPERATIVE APPOINTMENTS WITH ANOTHER DOCTOR AND THE ACCOUNT HAS NOT RECEIVED POST-OPERATIVE NOTES ON THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713103 ↗
• MalfunctionFeb 17, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS BENDING/ FOLDING UP INSIDE THE PRELOADED CARTRIDGE. ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S LEFT EYE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. THE PATIENT HAS REPORTEDLY RECOVERED. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553175 ↗