TECNIS IOL DFR00V (REF DFR00VU205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05050474750685), received between Jan 12, 2022 and Nov 22, 2024 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Adverse 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 DURING A SECONDARY SURGICAL PROCEDURE DUE TO MECHANICAL COMPLICATIONS IN THE LEFT EYE DEFINED AS THE PATIENT WAS UNABLE TO DRIVE AT NIGHT DUE TO GLARE AND BLURRED VISION. THE INCISION WAS ENLARGED TO REMOVE THE LENS PRIOR TO INSERTION OF REPLACEMENT IOL. A REPLACEMENT LENS OF A DIFFERENT MODEL ZXW225, BUT OF THE SAME DIOPTER AS THE ORIGINAL LENS WAS USED. NO SUTURE OR VITRECTOMY WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME STATUS WAS REPORTED AS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20761989 ↗
• InjuryNov 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT COMPLAINTS OF VISION IS NOT AS CLEAR AS IT COULD BE. SHE IS NOT ABLE TO READ WITHOUT READING GLASSES AND CAN NOT SEE STREET SIGNS DUE TO BLURRINESS. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION IOL WITH 20.0 DIOPTER. UNCORRECTED AND BEST CORRECTED VISUAL ACUITY PRE-OPERATIVE WAS REPORTED AS: -0.50 +0.50 X 080 ADD: +2.50 20/20. UNCORRECTED AND BEST CORRECTED VISUAL ACUITY RESULTS POST-OPERATIVE ARE NOT AVAILABLE. THERE WAS NO MEDICAL INTERVENTIONS, NO SURGICAL INTERVENTIONS, AND NO PATIENT INJURY. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18070419 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT EXPERIENCED BLURRY VISION AND COULD NOT ADAPT TO THE IOL. THE PATIENT HAS A PRE-EXISTING DRY EYE CONDITION AND IS BEING TREATED WITH PLUGS AND EYE DROPS. THE DOCTOR TESTED THE PATIENT FOR DRY EYES AND WAS AWARE OF THE PRE-EXISTING CONDITION. THE PLUGS WERE INITIALLY TEMPORARY AND ARE NOW PERMANENT. REGARDING THE VISION, THE PATIENT REPORTED BEING UNABLE TO SEE CLOSER THAN ARM¿S-LENGTH, HOWEVER THIS WAS EXPLAINED TO THE PATIENT BY THE DOCTOR AND THE PATIENT WAS ¿OK WITH THAT¿. HOWEVER, THE PATIENT CANNOT SEE THE STOP SIGNS AND DRIVING IS A CHALLENGE. GOLFING HAS BECOME A CHALLENGE AS THE PATIENT REPORTED NOT BEING ABLE TO SEE THE BALL IF IT IS HIT MORE THAN 100 FEET. THE PATIENT STILL PERFORMS THESE ACTIVITIES. REPORTEDLY, THE SYMPTOMS WERE NOTICED ABOUT A WEEK AFTER THE IOL WAS IMPLANTED AND THE DOCTOR SAID GLASSES CANNOT FIX THE PROBLEM. INITIALLY THE DOCTOR STATED THAT THE PATIENT¿S BRAIN NEEDED MORE TIME TO NEURO-ADAPT. AFTER SEVERAL MONTHS, THE PATIENT DID NOT NEURO-ADAPT. THE DOCTOR RECOMMENDED AN EXPLANT WITH A MONOFOCAL AS A REPLACEMENT IOL. THE PATIENT SO

  Patient problems: Blurred Vision

  MAUDE report 17294946 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENTS LEFT EYE DUE TO DYSPHOTOPSIA IMAGE ISSUES WHICH PATIENT HAD BEEN COMPLAINING SINCE IMPLANTATION. THE DFR00V LENS WAS REPLACED WITH ZCB LENS. NO OTHER SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16857597 ↗
• InjuryFeb 20, 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 RIGHT EYE DUE TO MULTIFOCAL INTOLERANCE DESCRIBED AS HALOS/GLARE AND OTHER VISUAL DISTURBANCES. IT WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. IT WAS UNSPECIFIED IF THERE ARE OTHER ADVERSE EVENTS. THE PATIENT HAS RECOVERED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16401843 ↗
• InjuryFeb 10, 2023Adverse 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 LENS WAS EXPLANTED IN SECONDARY SURGICAL PROCEDURE DUE TO THE PATIENT BEING UNABLE TO GET USED TO THE GLARE AND HALOS AT NIGHT THAT ARE ASSOCIATED WITH THE IOL EVEN WITH CORRECTION. THE PATIENT ALSO FELT THAT THE DISTANCE VISION (DV) WAS NOT CRISP. THE PROBLEM WAS OBSERVED DURING POST-OPERATIVE EXAMINATION. A STANDARD IOL WAS IMPLANTED AS REPLACEMENT. THE INCISION WAS ENLARGED. NO SUTURE OR VITRECTOMY WAS REQUIRED. PATIENT OUTCOME WAS -0.50 -0.50X165 20/20 WITH CORRECTION. VISUAL ACUITY (VA) PRE-OPERATIVE WAS 20/20 + 0.75 SPHERE AND VA POST-OPERATIVE WAS 20/25 +2 WITHOUT CORRECTION. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE SYMPTOMS FIRST STARTED ON (B)(6) 2022 IN THE RIGHT EYE. A NON-JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PATIENT'S UNCORRECTED DISTANCE VISION POST-OPERATIVE IS 20/20-2. THERE ARE NO PLANNED INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 16356029 ↗
• MalfunctionOct 19, 2022Crack; Inaccurate Delivery; Crack; Inaccurate Delivery

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) POPPED OUT OF THE SIDE OF THE CARTRIDGE. THE LENS HAD MADE CONTACT WITH PATIENT'S RIGHT EYE, HOWEVER, WAS NOT INSERTED. THERE WAS NO OTHER INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER AND THE PATIENT WAS FINE POST OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629970 ↗
• InjuryOct 7, 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 THE PATIENT'S RIGHT EYE DUE TO BLURRY VISION. THE NEAR VISION OF THE PATIENT WAS BLURRIER. THE IOL WAS EXPLANTED AND ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT LENS. THE PATIENT WAS DOING GOOD POST-OPERATION. NO OTHER INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15558706 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTOLERABLE HALOS AND GLARE AT NIGHT IN THEIR RIGHT EYE (OD) RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). THE REPLACEMENT IOL WAS OF A DIFFERENT MODEL AND DIOPTER. THE IOL WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS STATED TO BE BIOHAZARD. THE EXPLANT PROCEDURE WAS SUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15525492 ↗
• InjuryAug 26, 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 VISUAL ISSUES OF DEBILITATING HALOS AND GLARE. THE EXPLANT WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL DCB00 20.5D, NO ADVERSE EVENTS. THE PATIENT WAS DOING WELL POST-OPERATIVELY (OP). SUSPECT LENS IS UNKNOWN IF COMING BACK FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15307543 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INITIALLY THAT THE DOCTOR PERFORMED LASIK ENHANCEMENTS ON PATIENTS WITH SYNERGY LENSES TO BRING THEIR VISION INTO OPTIMAL FOCUS. NO OTHER INFORMATION WAS RECEIVED. NEW INFORMATION WAS RECENTLY RECEIVED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. AN UNPLANNED VITRECTOMY WAS REQUIRED. EXPLANT WAS DUE TO PATIENT VISUAL ISSUES STILL THERE/BLURRY VISION AND PATIENT STATED THAT THE OVER-ALL QUALITY OF VISION WAS TERRIBLE DESPITE YTTRIUM ALUMINUM GARNET (YAG) DONE. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. IT WAS NOTED THAT THE PATIENT WAS OK POST-OPERATIVELY (OP). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15280882 ↗
• InjuryAug 18, 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 AS SURGEON STATED THAT DESPITE ACCURATE MEASUREMENTS PRE-OPERATIVELY, PATIENT ENDED UP WITH RESIDUAL MYOPIA CAUSING DYSPHOTOPSIA AND INABILITY TO FUNCTION. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER DFR00V, 19.0 DIOPTER SIZE POWER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE. NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15247232 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH CARE PROVIDER REPORTED THEY EXPLANTED JOHNSON & JOHNSON LENS FROM THE PATIENT'S RIGHT EYE, BECAUSE THEY WERE EXPERIENCING SUBJECTIVE VISUAL DISTURBANCES: HALOS AROUND LIGHT, GLARE, AND EYES FELT TIRED, HURT, ACHY, AND PAIN. PATIENT IS VERY SENSITIVE TO LIGHT. THEIR DISTANCE AND NEAR VISION IS BLURRY. THE ISSUES WERE OBSERVED DURING A POST-OPERATIVE (OP) EXAM. THE EXPLANTED IOL WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. THE PATIENT¿S CURRENT STATUS IS UNKNOWN. THIS PATIENT HAD BILATERAL EXPLANTS. THIS REPORT IS FOR THE RIGHT EYE MFR REPORT NUMBER 3012236936-2022-01253. THE LEFT EYE IS REPORTED VIA MFR REPORT NUMBER 3012236936-2022-01254.

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

  MAUDE report 14459759 ↗
• 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 FROM A PATIENT'S OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE AS THE PATIENT WAS DISSATISFIED WITH HALOS. A NON-JOHNSON AND JOHNSON LENS OF 21.0 DIOPTER WAS USED AS THE REPLACEMENT IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 14274776 ↗
• InjuryApr 29, 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 RIGHT EYE DUE TO REFRACTIVE SURPRISE. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/60 AND POST-OPERATIVE ACUITY WAS 20/30. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14254958 ↗
• InjuryApr 8, 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 RIGHT EYE. A COMPETITOR BRAND IOL WAS IMPLANTED AS REPLACEMENT (DIOPTER +20.0). THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WERE REQUIRED. THE IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 14053585 ↗
• InjuryMar 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 LEFT EYE DUE TO CONSTANT "OILY" BLURRED VISION. A NEW INCISION WAS MADE TO REMOVE THE LENS WHOLE. THERE WAS NO PATIENT INJURY AND NO VITRECTOMY OR SUTURES REQUIRED. ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL, AAB00, SAME DIOPTER) WAS IMPLANTED AS REPLACEMENT. THE PATIENT REPORTED THE VISION WAS MUCH BETTER POST-OPERATIVELY AND THE EYE IS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13628301 ↗
• InjuryFeb 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL FAILURE. ACCOUNT INDICATED THAT THERE WAS INCISION ENLARGEMENT AND SUTURE PERFORMED. NO PATIENT INJURY WAS REPORTED POST-OPERATIVELY. FURTHER CLARIFICATION NOTED THAT THE EXPLANT WAS DUE TO BLURRED VISION, PATIENT DESCRIBED THAT IT WAS AS IF THERE WAS A WAXY FILM OVER THEIR VISION. THE BLURRED VISION DID NOT RESOLVE AND THE EXAMINATION ON (B)(6) 2022 CONFIRMED "MECHANICAL FAILURE" DUE TO PERSISTENT BLURRED VISION AND IOL MALPOSITION, IOL DECENTERED SLIGHTLY NASALLY. REPLACEMENT IOL WAS MODEL AAB00, 20.5 DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13460710 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE DUE TO BLURRY PORTRAIT VIEW AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 13434209 ↗
• InjuryJan 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 IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT COMPLAINT OF LIGHT BURSTS AT NIGHT AND HALOS WHICH THE PATIENT IS UNABLE TO DRIVE AT NIGHT. THE ISSUE WAS NOTICED DURING POST-OPERATIVE EXAMINATION, IMMEDIATELY AFTER THE SURGERY. A REPLACEMENT LENS OF DIFFERENT MODEL DCB00 OF 20.5 DIOPTER WAS USED. THERE WERE NO MEDICAL/SURGICAL INTERVENTIONS REQUIRED. NO PATIENT INJURY WAS REPORTED. THE PATIENT IS HAPPY WITH THE REPLACEMENT LENS AND NO LONGER HAS A COMPLAINT. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE IOL IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S LEFT EYE.

  Patient problems: Flashers; Halo

  MAUDE report 13322751 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED "LIGHTS BURSTING" AT NIGHT AND HALOS IMMEDIATELY AFTER THE INTRAOCULAR LENS (IOL) , MODEL DFR00V 20.5 DIOPTER, WAS IMPLANTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE). ACCOUNT PROVIDED THAT PATIENT WAS UNABLE TO DRIVE AT NIGHT AND DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE AND A DIFFERENT MODEL LENS (DCB00) WITH THE SAME DIOPTER POWER WAS IMPLANTED AS THE REPLACEMENT LENS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED, NO LONGER HAS COMPLAINTS, AND IS HAPPY WITH REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo

  MAUDE report 13287498 ↗
• InjuryJan 12, 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 UNEXPECTED POST-OPERATIVE (OP) REFRACTION OF -1.00. THE PATIENT HAD HALOS AND BLURRY VISION. ANOTHER JOHNSON & JOHNSON LENS OF SAME MODEL, BUT OF LOWER DIOPTER (19.0D) WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Halo; Visual Impairment

  MAUDE report 13240618 ↗