TECNIS IOL DFR00V (REF DFR00VU160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474750593), received between Dec 2, 2021 and Mar 9, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE DUE TO EXTREME DYSPHOTOPSIA, HOWEVER, ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE EXPLANT WAS PLANNED BUT NO INFORMATION WAS RECEIVED CONFIRMING THAT IT WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT IT WAS A DFR00V INTRAOCULAR LENS THAT WAS IMPLANTED IN THE PATIENTS LEFT EYE. DURING THE ONE WEEK POST OPERATIVE EXAMINATION ON (B)(6) 2023, INTRAOCULAR PRESSURE WAS ELEVATED TO 23 AND PATIENT HAD A PARACENTESIS DONE. THE VISION WAS OK BUT STILL BLURRY AT NEAR AND DISTANCE AND THE VISION WAS WORSE IN MORE LIGHTING. PATIENT HAD FOREIGN BODY SENSATION (FBS) SINCE THE MORNING OF THE ONE-WEEK EXAMINATION DATE. PATIENT WAS USING SIMBRINZA, PREDNISOLONE/MOXIFLOXACIN ONE DROP FOUR TIMES A DAY AND WAS ASKED TO CONTINUE USING PREDNISOLONE AND ALPHAGAN TWICE A DAY IN OS (OCULAR SINISTER). DURING POST OPERATIVE EXAMINATION ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT HAD WORN CONTACT LENS FOR 1.5 HOURS AFTER LAST APPOINTMENT, BUT EYE WAS TEARY AND SCRATCHY SO TOOK OUT AND HASN'T WORN. THE INTRAOCULAR PRESSURE WAS IMPROVED TO16 AND CORNEA WAS CLEAR. THE PATIENT WAS ASKED TO CONTINUE THE SAME

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Foreign Body Sensation in Eye; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 16514358 ↗
• InjuryOct 28, 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 BLURRY VISION WHICH THEY CLAIM SIGNIFICANTLY INTERFERES WITH PATIENT'S DAILY ACTIVITIES. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. THE REPLACEMENT LENS IS A NON JOHNSON AND JOHNSON IOL. PATIENT FINE POST-EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15688291 ↗
• InjurySep 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FOR AN UNSPECIFIED REASON. THE LENS WAS DISCARDED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE REASON THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE WAS DUE TO LENS DISLOCATION. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZA9003 16.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS UNAVAILABLE. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15507244 ↗
• InjurySep 12, 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 EXPERIENCING DYSPHOTOPSIAS THAT WERE NOT MORE EXTREME THAN NORMAL. IT WAS STATED THAT PRODUCT WILL NOT BE RETURNED AS IT WAS NOT KEPT AFTER THE EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15407097 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT TOLERATE AND ADJUST TO THE MULTI FOCAL PROPERTIES OF THE INTRAOCULAR LENS (IOL) RESULTING IN THE NEED TO EXPLANT THE IOL FROM THE RIGHT EYE OF THE PATIENT. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND A DIFFERENT LENS MODEL (DCB00) WITH THE SAME DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT WAS STATED TO TOLERATE THE PROCEDURE WELL. THE IOL WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED AFTER REMOVAL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 14952197 ↗
• InjuryJan 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO MECHANICAL FAILURE CONSISTING OF SPIDER WEB GLARE DISTORTION WITH DISTANCE VISION. ACCOUNT INDICATED THAT THE LENS WAS REMOVED IN ONE PIECE. THE INCISION WAS ENLARGED; HOWEVER, NO VITRECTOMY OR SUTURES WERE REQUIRED. THE IOL WAS REPLACED WITH LENS MODEL AAB00, +17.0 DIOPTER POWER. THE PATIENT IS REPORTEDLY SEEING WELL AND IS VERY HAPPY WITH THE NEW LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 13182588 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT'S OCULAR DEXTER (RIGHT EYE). THE PATIENT STATED THAT HE DID NOT WANT THE IOL MEDI-CAL BECAUSE HE WOULD STILL NEED READING GLASSES, SO HE OPTED FOR THE TOP OF THE LINE IOL. THE PATIENT IS SATISFIED WITH READING, BUT NOT WITH DISTANCE. BEFORE THE PATIENT HAD SURGERY, HE HAD CONTACTS AND STATES HE COULD SEE BETTER WITH HIS CONTACTS. THE PATIENT WAS HOPING FOR 20/20, BUT HIS RIGHT EYE IS WORSE THAN THE LEFT EYE. THE PATIENT IS VERY UNHAPPY WITH HIS RIGHT EYE AND INDICATED THAT HE IS NOT GETTING THE RESULTS HE WAS EXPECTING. HE DEER HUNTS OFTEN, AND NOW HE CANNOT SEE GOOD ENOUGH OUT OF HIS RIGHT EYE TO MAKE A GOOD DECISION. ACCORDING TO THE PATIENT, THE DOCTOR DID A SMALL PROCEDURE FOR ASTIGMATISM AND HE IS WAITING TO SEE HOW IT GOES. NO FURTHER INFORMATION IS AVAILABLE. RIGHT EYE: 20/60. LEFT EYE: 20/20 ¿ 20/25, THE PATIENT IS SATISFIED WITH THIS EYE.

  Patient problems: Blurred Vision

  MAUDE report 12919162 ↗