TECNIS IOL DFR00V (REF DFR00VU210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05050474750692), received between Aug 24, 2021 and Jun 9, 2025 — classified as 26 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO THE PATIENT COMPLAINING OF BLURRY VISION THAT DID NOT IMPROVE. THIS LENS WAS REPLACED WITH AN UNKNOWN IOL DURING A SECONDARY SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22169881 ↗
• InjuryMar 20, 2025Adverse 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 AS THE PATIENT HAD RETINA SURGERY. THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE AND IMPLANTED A SULCUS LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21656815 ↗
• InjuryDec 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE MULTIFOCAL LENS WAS EXPLANTED DUE TO SIGNIFICANT DECENTRATION OF THE IOL. THE LENS WAS THEN REPLACED WITH AN UNKNOWN NON-J&J LENS. THE PATIENT'S PRE-OPERATIVE VISION WAS 20/150, AND THEIR POST-OPERATIVE VISION IMPROVED TO 20/25. THE PATIENT IS DOING WELL AND HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 20888012 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED AFTER THE IMPLANTATION DUE TO MYOPIC SHIFT. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER MONOFOCAL J&J IOL. NO INJURY OR FURTHER INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT STATUS IS STABLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 20164398 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYNERGY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO PATIENT UNHAPPY WITH QUALITY OF VISION. THIS WAS REPLACED WITH A MONOFOCAL IOL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES, PERFORMED OR ANY PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT. THERE WAS NO PATIENT INJURY, PATIENT DOING FINE. SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 19757814 ↗
• InjuryJun 8, 2024Adverse 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 IMPLANTED IN THE PATIENT¿S LEFT EYE. AFTER THE IMPLANT, THE PATIENT EXPERIENCED BLURRY, CLOUDY VISION LIKE VASELINE IS IN HER EYE. SHE¿S EXTREMELY UNHAPPY WITH HER BLURRY VISION. SHE¿S ALSO EXPERIENCING PAIN. THE PATIENT EXPLAINED THAT THE PAIN IS MORE LIKE ACHINESS IN THE BACK OF HER LEFT EYE. WHEN SHE COVERS HER LEFT EYE SHE CAN SEE CLEARLY THROUGH HER RIGHT EYE. WHEN SHE DOES THE OPPOSITE AND COVERS HER RIGHT EYE THEN SHE CAN TELL THAT HER LEFT EYE IS CLOUDY, BLURRY. THE PATIENT HAS A PRE-EXISTING DRY EYE CONDITION AND IS BEING TREATED WITH PLUGS AND EYE DROPS. THE DOCTOR TESTED HER FOR DRY EYES AND WAS AWARE OF HER PRE-EXISTING CONDITION. THE PLUGS WERE INITIALLY TEMPORARY BUT ARE NOW PERMANENT. REGARDING HER VISION, THE CUSTOMER EXPLAINED THAT SHE¿S UNABLE TO SEE CLOSER THAN ARM¿S-LENGTH. HOWEVER, THE DOCTOR DID EXPLAIN TO THE PATIENT THAT THEY MAY NOT BE ABLE TO SEE CLOSER THAN ARM¿S-LENGTH AFTER THE SURGERY. PATIENT SAID SHE¿S ¿OK WITH THAT¿. HOWEVER, SHE CAN¿T SEE THE STOP SIGNS AND SHE THOUGHT SHE WOULD AFTER THE IMPLANTS. GOLFING HAS BECOME A CHALLENGE AS THE PATIENT REPORTED NOT BEING ABLE TO SEE TH

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 19493846 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED IN THE RIGHT EYE IN THE SECONDARY PROCEDURE. THE LENS WAS EXPLANTED AND REPLACED WITH DFR00VU 19.5D. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18411568 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR PERFORMED LENS EXCHANGE ON PATIENT'S RIGHT EYE (OD) DUE TO VISUAL DISTURBANCE. IT WAS INDICATED THAT THE DOCTOR WILL WAIT FOR THE OUTCOME OF EXPLANT OF THE RIGHT EYE (OD) TO SEE IF IT HELPS IMPROVE THE PATIENT'S ISSUE AND DOCTOR DOES NOT KNOW YET BUT IF NO VISUAL IMPROVEMENT, THEY WILL MOVE TO NEXT STEP FOR EXPLANTING THE LENS IN THE LEFT EYE (OS). THE REPLACEMENT FOR OD IS DCB00 19.5 DIOPTER (D) SIZE LENS. FURTHER INFORMATION CONFIRMED THAT REPORT WAS ACTUALLY FOR A BILATERAL LENS (OU) EXPLANT. APPARENTLY LEFT LENS (OS) EXPLANT OCCURRED BEFORE THE RIGHT LENS (OD) EXPLANT. THE LENS IN THE LEFT EYE WAS REPLACED WITH A DCB00, 20.5D. REASON FOR BOTH EXPLANTS WAS VISUAL DISTURBANCE. UNKNOWN IF THERE WAS ANY INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. PATIENT IS DOING WELL ON BOTH POST-EXPLANTS. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT LENS (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT LENS (OD).

  Patient problems: Visual Disturbances

  MAUDE report 17390894 ↗
• InjuryMay 22, 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 LEFT EYE DUE TO BLURRY VISION AT ALL DISTANCES, GLARE, INTOLERANCE TO MULTIFOCAL, VITRECTOMY PERFORMED (PPV - PARS PLANA VITRECTOMY) AND BIOM (BINOCULAR INDIRECT OPHTHALMOMICROSCOPE - FOR NON-CONTACT WIDE-ANGLE VITREOUS SURGERY). THE EXPLANTED IOL WAS REPLACED WITH A DIU150, +22.5DIOPTER POWER IOL. PATIENT OUTCOME GOOD. NO PATIENT INJURY. IT WAS NOTED THAT THE SUSPECT IOL IS NOT RETURNING FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16975208 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO BLURRY VISION AND GLARE. THE EXPLANTED IOL WAS DISCARDED. THE REPLACEMENT LENS IS A DCB00. THERE WAS NO PATIENT INJURY SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY OR SUTURES. REPORTEDLY, THE PATIENT IS DOING WELL POST OPERATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16574956 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DFR00V INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE.

  Patient problems: Blurred Vision; Eye Injury; Visual Disturbances

  MAUDE report 16547361 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DFR00V INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENTS LEFT EYE IN THE SECONDARY PROCEDURE AND REPLACED WITH COMPETITOR LENS BECAUSE PATIENT COMPLAINED OF BLURRY DISTANCE VISION AND SHADOWING. THERE WAS NO PATIENT INJURY AND NO MEDICAL AND SURGICAL INTERVENTIONS WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 16524903 ↗
• MalfunctionFeb 21, 2023Scratched Material; Scratched Material

  AFTER THE DFR00V INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) IT WAS REPORTED THE LENS WAS SCRATCHED. THE IOL WAS REMOVED AND THE SAME PROCEDURE WAS COMPLETED USING ANOTHER IOL WITH THE SAME MODEL AND A DIFFERENT DIOPTER SIZE, DFR00V 21.5 DIOPTER. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND IT WAS REPORTED THE PATIENT HAS RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415121 ↗
• InjuryFeb 16, 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 LEFT EYE DUE TO HALOS SUTURES WERE REQUIRED WHEN REMOVING THE IOL. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCB00 21.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME WAS REPORTED AS 20/30 ON (B)(6) 2023 WITH RESOLUTION OF HALOS. SUSPECT PRODUCT WILL NOT BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 16392466 ↗
• InjuryDec 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 OPERATIVE EYE FOR AN UNSPECIFIED REASON. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 21.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15920748 ↗
• InjuryNov 10, 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 DUE TO MECHANICAL FAILURE. THE ACCOUNT CLARIFIED THAT BY MECHANICAL FAILURE, THEY MEANT THAT THE PATIENT EXPERIENCED CONSTANT HALOS AROUND VISION DAY AND NIGHT, MAKING HER VISION BLURRY AND INTOLERABLE WHEN DRIVING. IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING ISSUE WHICH CONTRIBUTED TO THE REPORTED ISSUES. IT WAS INDICATED THAT NEW INCISIONS WERE MADE, AND THE LENS WAS TAKEN OUT WHOLE; HOWEVER, NO VITRECTOMY OR SUTURES WERE REQUIRED. ANOTHER JOHNSON AND JOHNSON LENS OF A DIFFERENT MODEL AND DIOPTER (MODEL AAB00, +19.5 D) WAS USED AS A REPLACEMENT. THE PATIENT IS STABLE, AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 15771737 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING HAZY VISION AND TROUBLE FOCUSING AND DRIVING OUTSIDE IN THEIR RIGHT EYE (OD) RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). ANOTHER JOHNSON AND JOHNSON LENS WAS PLACED AS THE REPLACEMENT IOL (MODEL DIB00, 21.5 DIOPTER POWER). NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WAS REQUIRED. THE PATIENT IS STATED TO BE DOING WELL POST-OPERATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15664188 ↗
• InjurySep 9, 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 "MECHANICAL FAILURE." THE INCISION WAS ENLARGED. NO SUTURES OR VITRECTOMY WERE REQUIRED. THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE "MECHANICAL FAILURE" WAS DETERMINED BY THE PATIENT'S VISUAL COMPLAINTS OF CONSTANT GLARE AND BLURRED VISION AS IF LOOKING THROUGH WATER. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, AAB00, SAME DIOPTER). IT IS UNKNOWN HOW THE PATIENT IS DOING POST-OPERATIVELY. THERE WAS NO DOCUMENTED ISSUE/MALFUNCTION WITH THE IOL ITSELF. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15388814 ↗
• InjuryAug 23, 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 INTO THE LEFT EYE, THE PATIENT COMPLAINED OF HALOS. THE IOL WAS EXPLANTED. A NON-JOHNSON & JOHNSON IOL OF THE SAME DIOPTER POWER WAS IMPLANTED AS A REPLACEMENT LENS. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED OR PLANNED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 15279195 ↗
• InjuryJul 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 DUE TO THE PATIENT NOT HAPPY WITH THE OUTCOME. A NON-JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT DIOPTER OF 21.5). THE INCISION WAS ENLARGED AND THE LENS WAS CUT IN HALF. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 15094622 ↗
• InjuryApr 24, 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 PATIENT'S LEFT EYE DUE TO THE PATIENT BEING DISSATISFIED AND NOT HAPPY WITH THE IOL AND THE "PORTRAIT VIEW" WAS BLURRY. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. A DIFFERENT MANUFACTURER'S IOL WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 14191161 ↗
• 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 A PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE AS PATIENT¿S VISION HAD NOT IMPROVED; THEY FELT LIKE THEY WERE ¿LOOKING OUT OF THE BOTTOM OF A COKE GLASS". THE PATIENT COMPLAINED OF "HAZY HALO" WHEN LOOKING AT POINTS OF LIGHT AND INDICATED THAT THE LENS EYE VISION IS "DEPRESSING". THE PATIENT DID NOT LIKE THE QUALITY OF THEIR VISION WITH THE SYNERGY LENS, WAS UNHAPPY AND REPORTEDLY THEY WOULD NOT BE SATISFIED WITH THEIR VISION EVEN IF THEY ARE PLANO REFRACTION. A NON-JOHNSON AND JOHNSON LENS OF 21.0 DIOPTER WAS USED AS THE REPLACEMENT. ANTERIOR VITRECTOMY WAS PERFORMED DURING THE EXPLANT. THERE WAS NO PATIENT INJURY, AND THE OUTCOME WAS REPORTED TO BE GOOD; ¿VISION IS DOING GREAT¿. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 14032132 ↗
• InjuryFeb 11, 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 LEFT EYE DUE TO HALOS AND GLARE FROM NIGHT DRIVING AND AS THE PATIENT EXPERIENCED VISUAL DISTURBANCE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. IT WAS INDICATED THAT THE DAILY ACTIVITIES OF THE PATIENT WERE NOT SIGNIFICANTLY AFFECTED, AND THE PATIENT HAS FULLY RECOVERED. THE PRE-OPERATION VISUAL ACUITY WAS 20/20- AND THAT POST-IMPLANTATION WITH THE LENS WAS 20/40-. ANOTHER LENS OF DIFFERENT MODEL (DCB00) AND HIGHER DIOPTER (21.5D) WAS USED AS THE REPLACEMENT AND THE VISUAL ACUITY AFTER THIS EXCHANGE WAS 20/60+2. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13519043 ↗
• MalfunctionFeb 8, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE AND THE TRAILING HAPTIC CAME OFF. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477360 ↗
• MalfunctionJan 25, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC WAS BENT/BROKEN DURING INSERTION IN THE LEFT EYE. THE LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE INCISION WAS ENLARGED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13348544 ↗