TECNIS IOL DFR00V (REF DFR00VU240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05050474750753), received between Jan 5, 2022 and May 19, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE BECAUSE THE PATIENT WAS NOT SEEING WELL AT ANY DISTANCE, WAS NEVER ABLE TO READ WITHOUT GLASSES, AND HER DISTANCE VISION ALWAYS FELT BLURRY. THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH THEIR DAILY ACTIVITIES. THERE WAS NO PATIENT INJURY SUCH AS A CAPSULE TEAR. NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. PRE-OPERATIVE UNCORRECTED AND BEST CORRECT VISUAL ACUITY WAS REPORTED AS 20/40. ONE DAY POST-OPERATIVE UNCORRECTED AND BEST CORRECTED VISUAL ACUITY 20/80. REPORTEDLY, THE PATIENT HAS NOT HAD 2 WEEKS POST-OPERATIVE YE (YEAR EVALUATION/ YEARLY EXAM). THE IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON MODEL RX SIGHT LAL 25.00. NO FURTHER INFORMATION IS AVAILABLE. NOTE. BOTH EYES WERE EXPLANTED. LEFT EYE REPORTED IN MANUFACTURER REPORT NUMBER 3012236936-2025-0002676.

  Patient problems: Blurred Vision

  MAUDE report 25220651 ↗
• InjuryJun 18, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT PATIENT HAD MULTIPLE ISSUES WITH THE PRELOADED INTRAOCULAR LENS (IOL) FOR OVER A YEAR AND A HALF AND FINALLY THE LENS WAS EXPLANTED FROM THE LEFT EYE AND REPLACED. IT WAS NOTED THAT THE LENS WAS DEFECTIVE. THROUGH FOLLOW-UP WITH THE PATIENT, IT WAS REPORTED SOON AFTER THE IOL WAS IMPLANTED IN THE LEFT EYE, THE PATIENT EXPERIENCED SEEING A SORT OF "CREASE" LINE HORIZONTALLY IN THE VISION, WHICH DISTORTED THE PATIENT'S VISION ABOVE AND BELOW THE "CREASE". THE ONLY WAY THE PATIENT WAS ABLE TO SEE WELL WAS IF THE LEFT EYE WAS COVERED. THE PATIENT REPORTED THAT THE SURGEON DID MULTIPLE TESTS (UNSPECIFIED), A LASIK PROCEDURE (UNKNOWN DATE), AND AN ADDITIONAL SURGICAL PROCEDURE TO RE-POSITION THE LENS (UNKNOWN DATE), BUT NOTHING HELPED AND THE SURGEON WAS UNABLE TO DETERMINE WHAT THE ISSUE WAS. THE PATIENT WAS VERY ANXIOUS OVER THE VISUAL ISSUE AND WAS PRESCRIBED WELLBUTRIN FOR THE ANXIETY, WHICH DID NOT HELP. AFTER A WHILE, THE IMPLANTING SURGEON INFORMED THE PATIENT THAT THERE WAS NOTHING MORE TO BE DONE. THE PATIENT THEN SOUGHT A DIFFERENT SURGEON WHO EXPLANTED THE LENS ON (B)(6) 2024. ANOTHER IOL WAS IMPLANTED AS REPLACEMENT (UNKNOWN LENS). THE PATIENT R

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

  MAUDE report 19564316 ↗
• InjuryJul 1, 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 EXPLANTED FROM A PATIENT¿S RIGHT EYE. THE PATIENT DESIRED TO HAVE THIS LENS EXPLANTED AND WAS NOT SATISFIED WITH SIGHT WITH A MULTIFOCAL LENS. ANOTHER JOHNSON AND JOHNSON LENS OF A DIFFERENT MODEL AND DIOPTER (ZCB00 24.0) WAS USED AS A REPLACEMENT. THE PATIENT¿S OUTCOME IS GOOD POST-EXPLANT. NO MEDICAL OR SURGICAL INTERVENTIONS AND NO INJURY WERE INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 17244352 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) CRACKED DURING INSERTION INTO A PATIENT'S LEFT EYE. CRACKED IOL WAS CUT AND REMOVED FROM EYE WITH FORCEPS AND A NEW ONE WAS PUT IN. THE PATIENT WAS DOING VERY WELL POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099803 ↗
• InjuryOct 27, 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 FOR AN UNKNOWN REASON. THE REPLACEMENT LENS IS A JOHNSON AND JOHNSON DCB00 24.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15681140 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH CARE PROVIDER REPORTED THAT THEIR PATIENT IS EXPERIENCING BLURRY VISION IN THEIR RIGHT EYE. THE SYMPTOMS WERE REPORTED ONE DAY POST-OP AND ARE NOT DEBILITATING. THERE WERE NO COMPLICATIONS OR SURGICAL INTERVENTIONS SUCH AS A CAPSULE TEAR, UNPLANNED VITRECTOMY OR SUTURES. THE IOL WAS SUBSEQUENTLY EXPLANTED. THE REPLACEMENT INFORMATION WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15071639 ↗
• InjuryJul 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 THEIR PATIENT EXPERIENCING ¿GHOSTING¿ WHICH THEY REPORTED AS VERY DEBILITATING. THE PATIENT IS A WELDER AND IT IS AN OCCUPATIONAL HAZARD. THE INCIDENT WAS REPORTED THE DAY AFTER SURGERY AND GHOSTING WAS EXPERIENCED FROM APRIL THROUGH JUNE UNTIL THE DAY OF THE EXPLANT. THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY, OR SUTURES REQUIRED. NO MEDICATION OUTSIDE OF THE REGULAR STANDARD OF CARE. THE REPLACEMENT LENS IS A DIFFERENT J&J MODEL DIB00 24.0 DIOPTER. REPORTEDLY, THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 14921999 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HALO AND GLARE RESULTING IN THE NEED FOR AN EXPLANT. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT IS REPORTED TO BE DOING OKAY. THE INTRAOCULAR LENS (IOL) WILL NOT BE RETURNED AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14838271 ↗
• InjuryMay 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO BLURRY DISTANCE VISION (DV) AS THE PATIENT WAS UNABLE TO READ STREET SIGNS. THE PATIENT OUTCOME: 20/40 -2, VISUAL ACUITY (VA) PRE-OPERATIVE (OP): 20/30 -1, AND VA POST-OP: 20/40 -2. THE IOL WAS DECENTERED DURING A POST-OP VISIT. MANIFEST REFRACTION (MRX) +0.25-0.50X35 20/50. SURGEON TRIED TO REPOSITION THE IOL, BUT HAD TO REMOVE AND REPLACE IOL. THE INCISION WAS ENLARGED, HOWEVER, THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. A MONOFOCAL LENS WAS IMPLANTED AS A REPLACEMENT. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE RIGHT EYE WAS AFFECTED. A NON-JOHNSON & JOHNSON LENS WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL WHEN DISCHARGED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14313718 ↗
• InjuryMay 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 DUE TO VISUAL DISTURBANCE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. IT WAS REPLACED WITH A DIFFERENT MODEL JOHNSON AND JOHNSON IOL (ZA9003) BUT SAME DIOPTER SIZE. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 14275158 ↗
• InjuryApr 21, 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 RIGHT EYE AS THE PATIENT WAS UNHAPPY WITH THEIR VISION CLARITY. A NON-JOHNSON & JOHNSON LENS 23.0 DIOPTER WAS USED AS THE REPLACEMENT LENS. AT EXPLANT, THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT, BUT A SUTURE WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT IS HAPPY POST-EXCHANGE, AND NO FURTHER SURGERY IS NEEDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14165286 ↗
• InjuryApr 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT AFTER IMPLANTING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S RIGHT EYE THEY EXPERIENCED STARBURSTS DYSPHOTOPSIA WHILE DRIVING. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIFFERENT JNJ LENS MODEL DCB00 26.0 DIOPTER. THERE WAS NO VITRECTOMY, SUTURES OR INCISION ENLARGEMENT REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers

  MAUDE report 14118800 ↗
• InjuryMar 8, 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 OPERATIVE EYE DUE TO BOTHERSOME GLARE AND HALOS WHEN DRIVING AT NIGHT. IT WAS STATED THAT THE PATIENT REQUESTED THE SUSPECT IOL TO BE REMOVED. THIS WAS REPLACED WITH A ZXR00 IOL BUT NO DIOPTER SIZE OR SERIAL NUMBER PROVIDED. THE PATIENT OUTCOME IS UNKNOWN. DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. IT WAS ALSO NOTED THAT THE IOL WAS DISCARDED. NO OTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13691702 ↗
• InjuryJan 27, 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 IN THE RIGHT EYE (OD) DUE TO DISTANCE VISION WAS NOT GOOD AND NEAR VISION IS OK, THE WORST AT NIGHT, WITH BAD GLARE AND HALOS. NEW COBWEB FLOATERS REPORTED 2 WEEKS AFTER SURGERY AND FLASHES WERE VERY FREQUENT AND VERY DISTRACTING. VISION IS STILL FOGGY. PATIENT FEELS VERY UNCOMFORTABLE DRIVING. PRE-OPERATIVE (OP) WAS 20/40 AND POST-OP IS 20/40. MILD CORNEAL SWELLING REMAINS, NO EDEMA ON MAC OPTICAL COHERENCE TOMOGRAPHY (OCT). IT WAS DISCUSSED WITH THE PATIENT THAT BLURRED VISUAL ACUITY (VA) IS ANTICIPATED TO IMPROVE AS EYE HEALS WITH RESIDUAL NEARSIGHTEDNESS NOTED. THERE WAS AN INCISION ENLARGEMENT DURING THE EXPLANT. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON DIB00 LENS (DIFFERENT MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING GREAT POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Flashers; Halo; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 13375056 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTING THE IOL INTO THE PATIENT¿S RIGHT EYE, THEY REPORTED BEING DISSATISFIED WITH THEIR VISION. THE PATIENT HAS BEEN SEEING GLARES AND HALOS AT NIGHT AROUND EVERYTHING AND HAS INCREASING LIGHT SENSITIVITY TO WHERE SHE IS WEARING SUNGLASSES INDOORS. THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. CONSEQUENTLY, THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THE CURRENT PATIENT STATUS IS UNKNOWN. IT WAS NOTED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13173390 ↗