TECNIS IOL DFR00V (REF DFR00VU180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474750630), received between Oct 28, 2021 and Jan 30, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Ejection Problem” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLURRY VISION AND DIFFICULTY FOCUSING ON DISTANT OBJECTS AND PRINTED MATERIALS FOLLOWING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DFR00V, IN THE RIGHT EYE. VISION WAS INITIALLY GOOD AFTER SURGERY; HOWEVER, APPROXIMATELY TWO YEARS AGO, THE PATIENT BEGAN EXPERIENCING INTERMITTENT EPISODES OF BLURRY VISION. THE PHYSICIAN DIAGNOSED DRY EYE AND PRESCRIBED LUBRICATING EYE DROPS, WHICH PROVIDED TEMPORARY IMPROVEMENT. ALTHOUGH THE DRY EYE SYMPTOMS LATER RESOLVED, THE PATIENT CONTINUES TO EXPERIENCE PERSISTENT BLURRY VISION RATHER THAN OCCASIONAL EPISODES. A YAG LASER TREATMENT WAS PERFORMED ONE MONTH AGO, BUT THE PROBLEM REMAIN. ACCORDING TO THE PATIENT, VISION SOMETIMES BECOMES VERY BLURRY AND PROBLEMATIC, WHILE AT OTHER TIMES IT IS CLEAR ENOUGH TO TOLERATE. THE COMPLAINT DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 24223038 ↗
• MalfunctionDec 28, 2024Ejection Problem; Ejection Problem

  ACCOUNT REPORTED THE LENS DID NOT COMPLETELY DEPLOY FROM THE CARTRIDGE AND WAS PARTIALLY INSERTED, REQUIRING REMOVAL WITH TISSUE FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW SAME LENS AND THE PATIENT WAS UNHARMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032095 ↗
• InjuryNov 22, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE PRE-LOADED DFR00V MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS DOUBLE VISION WITH GLARE AND HALOS. PATIENT IS UNABLE TO DRIVE AND READ. AN EXPLANT IS SCHEDULED BUT HAS NOT BEEN CONFIRMED TO HAVE TAKEN PLACE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 20765464 ↗
• InjuryJun 18, 2024Adverse 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 AND EXCHANGED WITH A SYMFONY OPTIBLUE LENS AS THE PATIENT WAS UNHAPPY WITH WITH DISTANCE VISION, NO REFRACTIVE ERROR. LENS IS NOT BEING RETURNED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 19564026 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO HAD BILATERAL LENS IMPLANTATION REPORTED OF HALOS, STARBURSTS, AND DOUBLE VISION ON BOTH EYES WHICH THINKS ARE DUE TO MECHANICAL ISSUES WITH THE LENSES. THE PATIENT STATED THAT IT IS HARD TO WORK, DRIVE AND READ, THAT SHE IS VERY DISAPPOINTED. THE PATIENT HAS ASTIGMATISM BUT NO OTHER HEALTH CONDITIONS. THE PATIENT REPORTED THE SYMPTOMS TO HER DOCTOR AND WAS TOLD TO WAIT A YEAR TO GET USED TO THE LENSES; HOWEVER, SHE STILL HAS THE SYMPTOMS. THE PATIENT DOES WORK, READ, AND DRIVE, BUT STATED THAT IT IS DIFFICULT. THE PATIENT DOES LIMITED DRIVING AT NIGHTTIME FROM WORK TO HOME WHICH TAKES THE SIDE STREETS AS SHE THINKS IT IS DANGEROUS FOR HER TO DRIVE MORE TO OTHER PLACES AT NIGHTTIME. NO SURGICAL OR MEDICAL INTERVENTIONS HAVE BEEN PERFORMED AND BOTH LENSES REMAIN IMPLANTED. THE PATIENT HAS SEEN A NEW DOCTOR WHO HAS OFFERED TO EXPLANT THE LENSES AND THE PATIENT IS SCHEDULED FOR THE RIGHT EYE LENS EXPLANT ON (B)(6) 2023, AND FOR THE LEFT EYE IN (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE PATIENT¿S LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT¿S RIGHT EYE.

  Patient problems: Flashers; Halo; Visual Impairment

  MAUDE report 18017058 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT WHO HAD BILATERAL LENS IMPLANTATION REPORTED OF HALOS, STARBURSTS, AND DOUBLE VISION ON BOTH EYES WHICH THINKS ARE DUE TO MECHANICAL ISSUES WITH THE LENSES. THE PATIENT STATED THAT IT IS HARD TO WORK, DRIVE AND READ, THAT SHE IS VERY DISAPPOINTED. THE PATIENT HAS ASTIGMATISM BUT NO OTHER HEALTH CONDITIONS. THE PATIENT REPORTED THE SYMPTOMS TO HER DOCTOR AND WAS TOLD TO WAIT A YEAR TO GET USED TO THE LENSES; HOWEVER, SHE STILL HAS THE SYMPTOMS. THE PATIENT DOES WORK, READ, AND DRIVE, BUT STATED THAT IT IS DIFFICULT. THE PATIENT DOES LIMITED DRIVING AT NIGHTTIME FROM WORK TO HOME WHICH TAKES THE SIDE STREETS AS SHE THINKS IT IS DANGEROUS FOR HER TO DRIVE MORE TO OTHER PLACES AT NIGHTTIME. NO SURGICAL OR MEDICAL INTERVENTIONS HAVE BEEN PERFORMED AND BOTH LENSES REMAIN IMPLANTED. THE PATIENT HAS SEEN A NEW DOCTOR WHO HAS OFFERED TO EXPLANT THE LENSES AND THE PATIENT IS SCHEDULED FOR THE RIGHT EYE LENS EXPLANT ON (B)(6) 2023, AND FOR THE LEFT EYE IN (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE PATIENT¿S RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT¿S LEFT EYE.

  Patient problems: Flashers; Halo; Visual Impairment

  MAUDE report 18017052 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO DYSPHOTOPSIA. HOWEVER, LATER THE SURGEON CLARIFIED THAT THE LENS WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE NOT DUE TO DYSPHOTOPSIA, BUT DUE TO THE PATIENT BEING UNHAPPY WITH THE DISTANCE VISION, NOT CLEAR TO HER. IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE DEBILITATING CONDITION. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO ADDITIONAL SURGICAL INTERVENTIONS REQUIRED. THE PATIENT OUTCOME WAS GOOD, AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 16288206 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT FROM A FEMALE PATIENT WHO HAD A JOHNSON AND JOHNSON INTRAOCULAR LENS (IOL) IMPLANTED IN BOTH EYES. SHE EXPERIENCED BLURRY VISION, DECREASED VISUAL ACUITY AND GLOWS/HALOS. AT APPROXIMATELY 10 FEET HER VISION STARTS TO BECOME BLURRY. WITH RAIN THE GLOW ON THE GROUND IS WHITISH OR GREYISH. THE PATIENT EXPLAINED THAT PRIOR TO THE IMPLANT HER VISION WAS 20/20 BUT AFTER THE IMPLANT IT IS 20/70 AND HAS DECREASED VISUAL ACUITY IN BOTH EYES. REGARDING HER RIGHT EYE, THE DOCTOR SAID THERE IS RIPPLING IN THE CAPSULE. INITIALLY THE DOCTOR THOUGHT THE RIPPLING WOULD RESOLVE ON ITS OWN BUT EVENTUALLY HAD TO PERFORM LASER SURGERY. IN RELATION TO HER LEFT EYE SHE REPORTED THE SAME SYMPTOMS BUT NO RIPPLING. HOWEVER, THE PUPIL IN HER LEFT EYE IS NOT CENTERED. REPORTEDLY, THE DOCTOR DID NOT SAY WHY THE PUPIL IS DECENTERED. BOTH EYES HAD LASER SURGERY PERFORMED AROUND (B)(6) 2022. SHE CONTINUES TO HAVE NIGHTTIME GLOW, BLURRY VISION AND NEEDS TO WEAR GLASSES DUE TO HER DECREASED VISUAL ACUITY. ALTHOUGH THE GLASSES RESOLVE HER VISION ISSUES, THE PATIENT REITERATED THAT SHE NEVER NEEDED GLASSES PRIOR TO THE IMPLANT. THE ONLY MEDICATION SHE IS ON IS KETORLAC EYE DROPS TWICE A DAY. NO FURTH

  Patient problems: Blurred Vision; Halo; Insufficient Information; Visual Impairment

  MAUDE report 15525340 ↗
• 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 DYSPHOTOPSIA SYMPTOMS IN THEIR RIGHT EYE RESULTING IN THE NEED FOR AN EXPLANT. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (DIB00 +18.5 D) WAS USED. THERE WERE NO SURGICAL OR MEDICAL INTERVENTIONS REQUIRED. THERE WAS NO PATIENT INJURY AND PATIENT IS STATED TO BE VERY HAPPY WITH THE REPLACEMENT LENS. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AS IT IS NOT AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 14838164 ↗
• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS UNHAPPY WITH HER VISION AS IT¿S NOT FOCUSED, BAD READING VISION WITH AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE. THE PATIENT COMPLAINED SINCE DAY 1 POST-OPERATIVE (OP). THE DOCTOR¿S OFFICE STATED THE SYMPTOMS WERE DEBILITATING AS THEIR VISION WAS ¿OUT OF FOCUS¿ EVEN WITH MANIFEST REFRACTION. THE PATIENT TRIED FOR ONE MONTH. THE MANIFEST WAS PLANO -0.25 TO 20/25. HOWEVER, THE SURGEON EXPLANTED THE IOL. ANOTHER JOHNSON & JOHNSON DIB00 LENS (DIFFERENT MODEL AND 18.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO CAPSULE TEAR, NO VITRECTOMY, AND NO INCISION ENLARGEMENT OR SUTURES NEEDED. REPORTEDLY, ONE DAY AFTER THE EXPLANT THE PATIENT¿S VISION SEEMS CRISPER. 20/30 WITH MILD EDEMA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14440012 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE DUE TO COMPLAINTS OF EXCESSIVE DYSPHOTOPSIA. THE INCISION WAS ENLARGED, HOWEVER NO SUTURE(S) WERE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 14215388 ↗
• InjuryOct 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 FROM THE PATIENT'S LEFT EYE DUE TO PATIENT UNABLE TO TOLERATE MULTIFOCAL IOL. IT WAS REPLACED WITH A DIFFERENT MODEL, SAME DIOPTER SIZE IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 12712988 ↗