TECNIS IOL DFR00V (REF DFR00VU225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474750722), received between Jul 28, 2021 and May 22, 2025 — classified as 22 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE PATIENT IS UNHAPPY WITH THE OUTCOME AS THEY COMPLAINED OF BLURRY VISION AND HALOS. THE INCIDENT WAS REPORTED TO THE DOCTOR AROUND 3-4 WEEKS AGO, MAKING THE INCIDENT DATE AROUND END OF MARCH BEGINNING OF MAY. DURING THE IMPLANT OF THE IOL THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY SUTURES OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER JNJ LENS MODEL DXR00V 23.0 DIOPTER AND THERE WERE NO COMPLICATIONS. THE PATIENT IS DOING WELL. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 22075255 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD VISUAL ISSUES DURING THE NIGHT AS SHE SEES HALOS AND RINGS, AFTER BEING IMPLANTED A MULTIFOCAL INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE (OS). SHE SAID THAT SHE CAN READ AND WRITE OK, CAN DRIVE OK BUT AT NIGHT OR DURING DIM LIGHT IS WHEN SHE SEES RINGS WHICH BOTHER HER. NO MENTION OF BLURRY VISION. BUT THE RINGS ARE NOW MORE THAN WHEN THEY STARTED BEFORE, VERY IRRITATING TO HER. IT WAS STATED THAT EXPLANT OF THE IOL WAS PERFORMED BY ANOTHER DOCTOR AS THE PATIENT DID NOT LIKE TO GO BACK TO HER FORMER EYE SURGEON ANYMORE. PATIENT STATED THAT HER OS EXPLANT WAS REPLACED WITH A NON JOHNSON AND JOHNSON LENS WHICH SHE SAYS HAS HELPED ADDRESS HER HALOS CONCERNS WITH THE EXPLANTED LENS ONE. PATIENT SAID THAT HER VISION IS A LOT BETTER NOW AND SHE DOES NOT HAVE ANY ISSUE WITH HER OS EYE ANYMORE. NO PATIENT POST-OP COMPLAINTS FROM THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 19603124 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE PATIENT WAS DISSATISFIED WITH THEIR VISION AS THEY WERE EXPERIENCING DYSPHOTOPSIA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 19188601 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFR00V 22.5 DIOPTER 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 INCREASED GLARE AND HALOS WITH NIGHT DRIVING. PATIENT ALSO HAD DIFFICULTY SEEING DISTANCE AT NIGHT, STREET SIGNS. THE EXPLANTED IOL WAS REPLACED WITH A DIB00 22.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, NO DELAY IN PROCEDURE, NO MEDICAL ATTENTION OR MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE). BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE: 20/20 AND BCVA POST-OPERATIVE: 20/20. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18683090 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFR00V 22.5 DIOPTER 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 HALOS AND GLARE. PATIENT REPORTED SHE COULD NOT DRIVE AT NIGHT DUE TO POOR VISION LOOKING AT DISTANT OBJECTS, STREET SIGNS. HER READING VISION WAS PERFECT. PATIENT ALSO EXPERIENCED SWELLING. ACCOUNT PROVIDED INFORMATION CONFIRMING REPLACEMENT IOL WAS A DIB00 23.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, NO DELAY IN PROCEDURE, NO MEDICAL ATTENTION OR MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE). BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE: 20/20 AND BCVA POST-OPERATIVE: 20/20. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Swelling/ Edema; Visual Disturbances

  MAUDE report 18585580 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT LEFT EYE. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO DISTORTED VISION. REPORTEDLY ANOTHER MULTIFOCAL IOL FROM JOHNSON & JOHNSON SURGICAL VISION, INC WAS USED AS REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17725795 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THEM EXPERIENCING HALOS AND GLARE. THE IOL WAS REPLACED WITH A NON JNJ LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16820493 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT SHE DID NOT HAVE SUCCESS WITH THE CATARACT PROCEDURE ON THE RIGHT EYE. THE PATIENT WAS NOT ABLE TO SEE VERY WELL, HAD BLURRY VISON, EXPERIENCES LOTS OF GLARES AND COULD NOT SEE AT NIGHT FOR ABOUT 3 MONTHS. THE DOCTOR PLANNED TO DO A LENS EXCHANGE ON (B)(6) 2022 AND IMPLANT A STANDARD LENS. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS SCHEDULED. THE REPLACEMENT IOL IS A STANDARD LENS OF DIFFERENT MODEL AND DIOPTER, DIB00 (+23.0 D). NO OTHER ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED AT THE TIME OF EXPLANT. THE PATIENT INDICATED THAT WITH THE NEW DIB00 LENS IMPLANT, THE VISION IS BETTER THAN WHAT SHE HAD WITH THE SYNERGY LENS, BUT STILL IS NOT GOOD WHICH THE DOCTOR TOLD HER TO WAIT. THE PATIENT IS VERY BOTHERED BY DAY LIGHT EVENT WITH SUNGLASSES AND HAS A HARD TIME SEEING DURING THE DAY UNLESS IT IS OVERCAST/CLOUDY. THE PATIENT STILL HAS THE BLURRY / POOR VISION WHICH THE DOCTOR TOLD HER IS DUE TO THE SCAR TISSUES AND ASKED THE PATIENT TO GO BACK FOR LASER SURGERY TO RESOLVE THE ISSUE AND IMPROVE THE VISION. THE PATIENT INDICATED THAT SHE CANNOT DRIVE OR SEW WHICH SHE USED TO DO BEFORE THE SURGERY. THE PATIENT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances

  MAUDE report 16649539 ↗
• MalfunctionJul 29, 2022Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS GOUGED AT THE EDGE BY THE PUSHER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15133650 ↗
• InjuryJul 28, 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 DUE TO THE PATIENT EXPERIENCING HALOS AND GLARE. THE EXPLANTED IOL WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER. THE PATIENT OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15127042 ↗
• InjuryJul 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 THE PATIENT'S LEFT EYE DUE TO FUZZY VISION. THE PATIENT ALSO NOTED THAT THEY COULD SEE THE SIDE OF THEIR LENS. A DFR00V MODEL LENS, 21.0 DIOPTER SIZE, WAS IMPLANTED AS THE REPLACEMENT IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES PERFORMED. THE PATIENT WAS DOING GOOD POST-EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14940816 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH CARE PROVIDER REPORTED THEY EXPLANTED AN INTRAOCULAR LENS (IOL) DUE TO PATIENT EXPERIENCING INTOLERABLE DYSPHOTOPSIA. THE IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS OF THE SAME DIOPTER. THE PROBLEM WAS NOTICED DURING A POST-OP EXAM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 14432249 ↗
• 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 THE PATIENT'S RIGHT EYE DUE TO HAVING COMPLAINTS WITH FAR VISION. THE SUSPECT IOL WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. PATIENT WAS REPORTEDLY FINE POST-EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14029337 ↗
• MalfunctionMar 9, 2022Contamination; Contamination

  DOCTOR REPORTED THAT WHILE IMPLANTING THE INTRAOCULAR LENS (IOL) HE HAD SOMETHING STUCK TO THE POSTERIOR PART OF THE OPTIC AFTER INSERTING THE IOL IN THE CAPSULAR BAG. HE WAS NOT ABLE TO REMOVE THE PARTICLE WITH THE IRRIGATION/ASPIRATION HANDPIECE. IT WAS ULTIMATELY REMOVED WITH FORCEPS. HOWEVER, THE PARTICLE WAS NOT SAVED FOR EVALUATION. ACCOUNT INDICATED THAT NO MARK WAS LEFT ON THE LENS AND THERE WAS NO PATIENT INJURY. THE IMPLANT WAS LEFT IN THE EYE AND WAS CLEAR AND CENTERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714467 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT EXPERIENCED POSITIVE DYSPHOTOPSIA, WITH DISTORTED VISION OR BRIGHT LIGHTS CAUSING WEIRD REFLECTIONS IN THE VISION. FURTHER INFORMATION WAS PROVIDED THAT THE PATIENT WAS NOT CORRECTABLE TO BETTER THAN 20/30 WITH REFRACTION AND CONTACT LENS OVER-REFRACTION. THE PATIENT HAD AN IOL EXCHANGE WITH A MONOFOCAL IOL, AND THE DOCTOR IS AWAITING STABILIZATION PRIOR TO DETERMINING THE PATIENT'S FINAL OUTCOME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Flashers; Visual Impairment

  MAUDE report 13691007 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING "VISUAL COMPLAINTS" IN THE LEFT EYE AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED. THE DOCTOR TRIED TO ADJUST THE POSITION OF THE LENS IN A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2021, IN AN ATTEMPT TO CORRECT THE "VISUAL COMPLAINTS," BUT THE PATIENT CONTINUED TO COMPLAIN. AN EXPLANT WAS PERFORMED IN A SEPARATE PROCEDURE. THERE WERE NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL, ZXT150 AND DIFFERENT DIOPTER, 23.5) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATIVELY. THERE IS NO FURTHER INFORMATION AVAILABLE FOR THIS EVENT.

  Patient problems: Visual Disturbances

  MAUDE report 13290990 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S OCULAR SINISTER (LEFT EYE) IN A SEPARATE SURGICAL PROCEDURE DUE TO COMPLAINTS OF DYSPHOTOPSIA. THE IOL WAS REPLACED WITH A DIFFERENT MODEL LENS (DIB00) OF THE SAME DIOPTER (2.5 D). THERE WAS NO VITRECTOMY, NO UNPLANNED INCISION ENLARGEMENT, AND NO UNPLANNED SUTURE(S) REQUIRED. NO PATIENT INJURY WAS REPORTED. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS 20/30+2. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 13247031 ↗
• InjuryJan 5, 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 GLARE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Visual Disturbances

  MAUDE report 13165993 ↗
• InjuryJan 4, 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 LEFT EYE DUE TO EXCESSIVE DYSPHOTOPSIA. THE SUSPECT IOL WAS REPLACED WITH A DIFFERENT MODEL (DIB00) BUT SAME DIOPTER POWER LENS. FURTHER FOLLOW-UP INDICATED THAT THE INCISION WAS SLIGHTLY WIDENED TO ACCOMMODATE THE EXPLANTATION AND CONFIRMED THAT THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 13160684 ↗
• InjuryNov 17, 2021Adverse 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 ABOUT 3 MONTHS AGO, AND EXPLANTED THIS WEEK DUE TO PATIENT BEING AN ARTIST FOUND THAT THE "CONTRAST" QUALITY WAS NOT THERE AFTER IOL WAS IMPLANTED. THE SUSPECT IOL WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON EYHANCE MONOFOCAL. THIS PATIENT IS DOING OK. SUSPECT IOL IS NOT BEING RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 12829469 ↗
• InjuryNov 11, 2021Adverse 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 RESIDUAL REFRACTIVE ERROR. A REPLACEMENT LENS OF THE SAME MODEL BUT DIFFERENT DIOPTER (22.0) WAS USED. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. REPORTEDLY THE PATIENT IS DOING WELL POST-OPERATIVE (OP) AND NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12796955 ↗
• InjuryNov 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DFR00V MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO PATIENT REPORTING SIGNIFICANT HALOS AND POOR CONTRAST SENSITIVITY. THE REPLACEMENT LENS WAS OF A DIFFERENT MODEL AND DIOPTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12755721 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYNERGY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE. THE PATIENT WAS NOT HAPPY WITH NEAR OR FAR VISION DURING THE NIGHT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12451401 ↗
• InjuryJul 28, 2021Adverse 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 DUE TO THE PATIENT COULD NOT PINHOLE TO BETTER THAN 20/40. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY REQUIRED. THE PATIENT IS DOING FINE POST-EXPLANT. AB 20/40, PH 20/40 CORRECTED DISTANCE, 20/30 INTERMEDIATE, J3 REFRACTION 20/30 -.25-.50, MAC/OCT (MACULAR/OPTICAL COHERENCE TOMOGRAPHY) HAD NORMAL PRE AND POST -OPERATIVE (OP) SCAN. THE EXPLANTED LENS WAS REPLACED WITH AAB00 IOL, BUT THE SERIAL NUMBER IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Eye Irritation; Foreign Body Sensation in Eye; Headache; Red Eye(s); Visual Impairment

  MAUDE report 12243032 ↗