TECNIS IOL DFR00V (REF DFR00VU230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05050474750739), received between Sep 16, 2021 and May 1, 2025 — classified as 22 injuries.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD CATARACT SURGERY IN LEFT EYE. POST OP PATIENT WAS UNABLE TO ADAPT AND THE LENS WAS EXPLANTED AND REPLACE WITH A NON-JNJ INTRAOCULAR LENS IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS GOOD. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21946740 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE DUE TO MECHANICAL COMPLICATIONS OF IOL WHICH THE PATIENT¿S VISION WAS BLURRY AND THE PATIENT WAS UNABLE TO TOLERATE THE LENS. PATIENT¿S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE PATIENT IS STATUS POST (S/P) YTTRIUM-ALUMINUM-GARNET (YAG) SO A PLANNED VITRECTOMY WAS REQUIRED. IT WAS INDICATED THAT THE YAG WAS DONE DUE TO POSTERIOR CAPSULE OPACIFICATION (PCO) THAT HAD A SIGNIFICANT IMPACT ON THE PATIENT¿S VISON AT 5 WEEK POST-OP APPOINTMENT. AFTER THE LENS EXPLANTED, A NON-JOHNSON AND JOHNSON LENS OF 23.0 DIOPTER WAS USED AS A REPLACEMENT LENS. NO INCISION ENLARGEMENT OR SUTURES REQUIRED AND NO DELAY IN PROCEDURE REPORTED. MEDICATIONS (PREDNISOLONE 1% -MOXIFLOXACIN 0.5% - BROMFENAC 0.075% 1 DROP 4 TIMES A DAY /1 GTT QID IN THE RIGHT EYE) PRESCRIBED WERE STANDARD OR CARE DROPS WHICH ARE GIVEN TO PATIENTS BEFORE AND AFTER ANY LENS PROCEDURE. THE PATIENT IS TEMPORARILY IMPAIRED. VISION PRE-OPERATIVE WITH CORRECTION 20/15-1 AND VISION POST-OPERATIVE WITHOUT CORRECTION 20/40. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Posterior Capsule Opacification

  MAUDE report 19141264 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT'S EYE DUE TO THE PATIENT'S DIFFICULTY DRIVING AT NIGHT AND DYSPHOTOPSIA. THE SUSPECT IOL WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL IN A SECONDARY SURGERY. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 18850462 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) DUE TO MYOPIA, GLARE AND HALO. PATIENT WAS NOT HAPPY WITH RESULTS. THE IOL WAS REPLACED WITH A COMPETITOR IOL, SAME DIOPTER POWER SIZE. THE REPLACEMENT LENS WAS ABLE TO HELP ADDRESS THE PATIENT¿S CONCERN. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES DONE. THE PATIENT IS PLEASED SO FAR, NO PATIENT POST-OP INJURY. NEW INFORMATION RECEIVED THAT LEFT EYE (OS) WAS PLANNED TO BE REMOVED ON (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS) LATER ON IF THAT EVENT IS ALSO DETERMINED TO BE REPORTABLE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 18603489 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE BECAUSE OF PATIENT COMPLAINT WITH SYNERGY LENS THAT THERE WAS A 'SMUDGE' IN VISION. AN ENHANCE LENS WAS USED AS A REPLACEMENT LENS. THE SUSPECT IOL WAS NOT SAVED SO NOT RETURNING FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17761507 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INTRAOCULAR LENS IMPLANTED AND COMPLAINED OF BLURRY VISION OVERALL, HALOS AND POOR VISION, ESPECIALLY AT NIGHT AND WAS NOT HAPPY WITH THEIR VISUAL OUTCOME. THE DOCTOR RECOMMENDED A CONTACT LENS TO SEE IF THAT IMPROVED THEIR VISION BUT THE RESULTS WERE NEGLIGIBLE. LAST MANIFEST REFRACTION PRIOR TO THE EXCHANGE WAS -1.00 +0.50 X 178 WITH A BEST CORRECTED DISTANCE VISION OF 20/25. PATIENT DECIDED TO HAVE THE IOL EXCHANGED. THERE WERE NO OTHER COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THE IOL WAS EXPLANTED AND REPLACED WITH A NON JNJ LENS, MODEL RXSIGHT LIGHT ADJUSTABLE IOL. REPORTEDLY, THE EXPLANTED IOL WILL BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16915926 ↗
• InjuryMar 2, 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 IN A SECONDARY PROCEDURE FROM THE PATIENT'S LEFT EYE DUE TO BLURRY VISION. INITIAL OPENING OF THE ORIGINAL TEMPORAL PRIMARY CORNEAL INCISION, SIGNIFICANT INTRAOPERATIVE FLOPPY IRIS SYNDROME WITH IRIS PROLAPSE THAT REQUIRED CLOSING THIS PRIMARY INCISION WITH 10-0 NYLON SUTURES, CREATION OF A SECOND SUPERIOR PRIMARY CORNEAL INCISION WITH SLIGHT ENLARGEMENT FOR LENS EXPLANT WITH SUBSEQUENT 10-0 NYLON SUTURE CLOSURE. IT WAS CONFIRMED IT HAD NOTHING TO DO WITH THE PRODUCT. A VITRECTOMY WAS NOT REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZA9003 22.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. PATIENT OUTCOME REPORTED AS STILL HEALING FROM SURGERY. LAST VISIT, VISUAL ACUITY 20/100 WITH RESIDUAL CORNEAL FOLDS AND ANTERIOR CHAMBER REACTION, PENDING SUTURE REMOVAL AT FOLLOW UP IN 2 WEEKS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 16475655 ↗
• InjuryFeb 17, 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 THE PATIENT'S OPERATIVE EYE DUE TO TOO MUCH GLARE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16399220 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO DYSPHYOTOPSIA. THE ISSUE WAS OBSERVED AFTER IMPLANTATION. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16383380 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFR00V INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IOL WAS EXPLANTED AND REPLACED WITH A AAB00 22.0 DIOPTER IOL DUE TO COMPLAINTS OF MECHANICAL FAILURE. THERE WAS NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER, THE INCISION WAS ENLARGED. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING MECHANICAL FAILURE AS SEVERE HALOS AFFECTING PATIENT'S NIGHT VISION AND SHE IS UNABLE TO SEE CLEAR ENOUGH TO READ THE ROAD SIGNS. PATIENT STATUS POST-LENS EXCHANGE WAS REPORTED AS STABLE AND HALOS HAVE DIMINISHED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16280524 ↗
• InjuryNov 11, 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 COMPLAINING OF CLOUDS IN VISION AND NOT ABLE TO READ LIKE BEFORE. IT WAS STATED THAT IT WAS UNKNOWN IF THERE WAS LOSS OF 2 OR MORE LINES OF BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY). ANOTHER JOHNSON & JOHNSON LENS, MODEL ZMB00 22.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. A YTTRIUM ALUMINUM GARNET (YAG) WAS DONE ON (B)(6) 2022 PRIOR TO THE LENS BEING EXPLANTED. PATIENT IS GOOD, DOING WELL POST-OPERATIVELY (OP). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15777713 ↗
• InjuryNov 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 THE PATIENTS RIGHT EYE FOR AN UNSPECIFIED REASON. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Eye Injury; Halo; Visual Disturbances

  MAUDE report 15757130 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO BLURRY VISION. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/30 AND POST-IMPLANTATION WITH THE ORIGINAL LENS, IT WAS 20/50 UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/29 (INITIALLY INDICATED AS -1.0 20/20). ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. POST-EXPLANT, THE VISUAL ACUITY WAS 20/25 AND THE PATIENT WAS DOING WELL. THE INCISION WAS ENLARGED TO REMOVE THE IOL FROM THE EYE BUT NO VITRECTOMY REQUIRED AND NO SUTURES WERE DONE. THERE WAS NO DELAY IN PROCEDURE REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15495029 ↗
• InjuryJul 1, 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 FROM THE RIGHT EYE DUE TO A REFRACTIVE ERROR THAT WAS IDENTIFIED DURING A POST-OPERATIVE EXAM. NO MEDICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN OF THE PATIENT'S DAILY ACTIVITIES FOR SIGNIFICANTLY AFFECTED. NO VITRECTOMY WAS REQUIRED. NO MEDICATION WAS PRESCRIBED. PATIENT STATUS IS TEMPORARILY IMPAIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 14889514 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT WAS UNHAPPY WITH THE VISUAL RESULTS. THE PATIENT INDICATED "FELT LIKE VASELINE COATING WAS OVER VISION AND COULD NOT SEE ACROSS THE STREET." THE PATIENT ALSO EXPERIENCED ISSUES WITH GLARE AND HALOS. IT IS NOTED THAT THE OUTCOME SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. YTTRIUM ALUMINUM GARNET (YAG) WAS RECOMMENDED, BUT THE PATIENT SOUGHT A SECOND OPINION AND WAS ADVISED THAT AN IOL EXCHANGE WAS NEEDED. AN EXPLANT WAS PERFORMED AND A NON-JOHNSON & JOHNSON BRAND IOL WAS IMPLANTED AS THE REPLACEMENT LENS. THE EXPLANTED DEVICE WAS DISCARDED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14760383 ↗
• InjuryApr 25, 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 COMPLAINTS OF UNBEARABLE GLARE AND HALOS, UNABLE TO DRIVE AT NIGHT. INCISION WAS ENLARGED. REPLACEMENT IOL WAS A NON JOHNSON AND JOHNSON IOL 22.0 DIOPTER SIZE. PATIENT WAS DOING WELL POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14197636 ↗
• InjuryApr 25, 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 FROM THE RIGHT EYE AFTER THE PATIENT WAS UNABLE TO ADAPT TO THE IOL. THE PATIENT EXPERIENCED SUBJECTIVE VISUAL DISTURBANCES, WHICH PERSISTED FOR SIX MONTHS. DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE SYMPTOMS WERE INITIALLY OBSERVED DURING A POST-OPERATIVE EXAMINATION. NO VITRECTOMY, SUTURES, INCISION ENLARGEMENT, OR MEDICATION WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. THE END-USER DID NOT SEEK ANY MEDICAL ATTENTION. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, ZA9003, DIFFERENT DIOPTER OF 22.5). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 14197530 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED THE PATIENT HAD A DECREASE IN DISTANT AND COLOR VISION IN THE LEFT EYE. THE PATIENT EXPERIENCED SOME ISSUES SEEING VIBRANT, CONTRAST IN COLORS. AN IOL EXCHANGE WAS PERFORMED. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIB00, DIFFERENT DIOPTER +22.5). MST MICRO FORCEPS AND SCISSORS WERE USED TO BISECT THE LENS AND THE TWO PIECES WERE REMOVED AFTER SLIGHTLY ENLARGING THE ORIGINAL PRIMARY INCISION WITH A 2.5 MM MICROKERATOME BLADE. THERE WAS NO PATIENT INJURY. THE PATIENT HAS NO COMPLAINTS POST-OPERATIVELY AS OF (B)(6) 2022. THE EXPLANTED IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14191552 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS BILATERAL IMPLANTS. A SYNERGY INTRAOCULAR LENS (IOL) IN THE LEFT (OS) EYE AND A NON-JOHNSON & JOHNSON LENS (PANOPTIX) IN THE RIGHT (OD) EYE. THE PATIENT COMPLAINED OF HALOS WITH ONCOMING TRAFFIC, POOR VISION, AND BLURRY VISION IN THE LEFT EYE. PATIENT ALSO STATED THAT THE LEFT EYE HAS MORE RINGS THAN THE RIGHT EYE AND GLOWS LARGER IN THE LEFT EYE. PATIENT IS "MORE SENSITIVE" TO GLARE IN THE LEFT EYE. SINCE THE PATIENT WAS HAPPY WITH THE PANOTIX LENS, THE LENS IN THE LEFT EYE WAS EXPLANTED AND THE PATIENT IS HAPPY WITH THE PANOPTIX, NON-JOHNSON & JOHNSON REPLACEMENT LENS. THERE WAS NO PATIENT INJURY, NO VITRECTOMY, AND THE PATIENT LEFT SURGERY WITHOUT COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 13905134 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTING AN INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT 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. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13173008 ↗
• InjuryOct 27, 2021Appropriate 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 BREAKDOWN OF THE IOL. THE REPLACEMENT LENS WAS OF THE SAME MODEL. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708604 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL SYNERGY INTRAOCULAR LENS (IOL) EXCHANGE DUE TO HALOS, COULDN¿T SEE STREET SIGNS, AND HALOS WERE BLINDING. THE PATIENT WAS 20/20 DISTANCE, 20/16 INTERMEDIATE, AND J1+ NEAR. THE REPLACEMENT IOLS WERE EYHANCE, AND THE PATIENT IS HAPPY. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE SUSPECT PRODUCT WITH SERIAL NUMBER (B)(4). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER SUSPECT PRODUCT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12485767 ↗