TECNIS IOL DXR00V (REF DXR00VU115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474761629), received between Nov 8, 2022 and Jan 27, 2025 — 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.

• MalfunctionJan 27, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT THE CARTRIDGE OF THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) DID NOT WORK AS INTENDED CRACKED AT THE TIP. THERE WAS A LOT OF RESISTANCE, AND THE TIP CRACKED. THE IOL DID NOT CONTACT THE EYE ONLY THE CARTRIDGE TIP. THE DEVICE WAS REMOVED AND REPLACED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242444 ↗
• 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 18384340 ↗
• InjuryDec 12, 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 DXR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT 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 18311941 ↗
• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAS A DEFECTIVE LENS/SIMPLICITY LOADER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757215 ↗