TECNIS IOL DFR00V (REF DFR00VU185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474750647), received between Jan 4, 2022 and Aug 30, 2023 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A SURGEON WILL BE EXCHANGING AN INTRAOCULAR LENS (IOL), MODEL DFR00V, 18.5 DIOPTER FOR AN EYHANCE DIU225 16.5 DIOPTER DUE TO A SIGNIFICANT REFRACTIVE MISS. THE PATIENT¿S CURRENT REFRACTION WAS -1.50/+1.50 × 66. NO SURGICAL OR MEDICAL INTERVENTIONS WERE INDICATED AT THE TIME. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EXPLANT HAS OCCURRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17651094 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM A PATIENT¿S LEFT EYE AS THE PATIENT COMPLAINED OF DOUBLE VISION SIDE TO SIDE AND A GLOW. A NON-JOHNSON AND JOHNSON LENS WAS USED AS THE REPLACEMENT. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED AND NO PATIENT INJURY REPORTED. THE PATIENT IS DOING WELL POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15883157 ↗
• InjuryNov 29, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical 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 DUE TO MECHANICAL FAILURE. THERE WAS AN INCISION ENLARGEMENT, AND THE LENS WAS REMOVED IN WHOLE, BUT NO VITRECTOMY OR SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Eye Injury

  MAUDE report 15883019 ↗
• InjuryOct 29, 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 WITH INCISION ENLARGEMENT DUE TO MECHANICAL FAILURE. IT WAS CLARIFIED THAT THE SPECIFIC MECHANICAL FAILURE WAS BECAUSE OF BLURRED DISTANT AND NEAR VISION, ESPECIALLY WHEN TRYING TO WORK AT THE COMPUTER. THE PATIENT ALSO REPORTED HALOS AND GLARE WITH VISION, ESPECIALLY WHEN TRYING TO DRIVE AT NIGHT. THE EXPLANTED IOL WAS REPLACED WITH AAB00 +18.0 DIOPTER. PATIENT NOTED TO BE IN STABLE CONDITION POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15696853 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BLURRY VISION AND GLARE IN THEIR RIGHT EYE (OD) RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). THE PATIENT'S PRE-OPERATION BEST CORRECTED VISUAL ACUITY (BCVA) IS 20/50. THE PATIENT'S POST-OPERATION UNCORRECTED VISUAL ACUITY (UCVA) IS 20/60 AND BCVA 20/50. THE TARGETED POST-OPERATION REFRACTION WAS 20/20. NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE REPLACEMENT IOL WAS A DIFFERENT JOHNSON AND JOHNSON LENS (MODEL DIU150,18.5 DIOPTER). THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15629653 ↗
• 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; Capsular Bag Tear; Halo; Visual Impairment

  MAUDE report 15525029 ↗
• InjurySep 27, 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." NO SUTURE OR VITRECTOMY WAS REQUIRED. THE INCISION WAS ENLARGED. THERE WAS NO PATIENT INJURY. AMVISC (BAUSCH + LOMB VISCOELASTIC) WAS USED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE "MECHANICAL FAILURE" WAS DETERMINED BY THE PATIENT'S REPORT OF CONSTANT BLURRED VISION WITH READING AND WORKING AT THE COMPUTER AND GLARE/HALOS WITH LIGHTS AT NIGHT. THERE WAS NO ISSUE/MALFUNCTION WITH THE IOL. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, AAB00, DIFFERENT DIOPTER OF +18.0). THE PATIENT IS DOING WELL AND IS VERY HAPPY WITH IMPROVED QUALITY OF VISION WITH EXCHANGED IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15491801 ↗
• InjuryJul 28, 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 IN A SECONDARY SURGICAL PROCEDURE DUE TO THE PATIENT EXPERIENCING UNBEARABLE HALOS, SHADOWING, VERTICAL DOUBLING, AND WAS UNABLE TO FUNCTION WITH THE LENS. PRE-OPERATIVE VISUAL ACUITY (VA) WAS 20/40 -1 AND POST-OPERATIVE VA WAS 20/60-2, VISION CORRECTED TO 20/20. THE PATIENT HAD POSTERIOR CAPSULE OPACIFICATION (PCO), BUT OPTED NOT TO HAVE YAG PERFORMED BUT TO EXPLANT INSTEAD. NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15122961 ↗
• InjuryJun 17, 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 AS THE PATIENT WAS SEEING STARBURSTS AT NIGHT WHILE DRIVING. ANOTHER LENS OF DIFFERENT MODEL AND LOWER DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND SUTURE WAS PLACED. THE PATIENT WAS HAPPY WITH THE VISION POST-OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers

  MAUDE report 14725168 ↗
• InjuryMay 31, 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 (OD) DUE TO PATIENT EXPERIENCING PERSISTENT HALOS AND GLARE AROUND POINTS OF LIGHT. ACCOUNT INDICATED THAT SYMPTOMS ONSET WAS A WEEK POST SURGERY. A COMPETITOR LENS WAS IMPLANTED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY REPORTED AND NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14554598 ↗
• MalfunctionMar 8, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, IT WAS NOTICED THAT THERE WAS A CRACK IN THE PERIPHERAL OF THE LENS. IT WAS REPORTED THAT THE "LENS MALFUNCTIONED COMING OUT AND BEING INJECTED INTO THE EYE." THE IOL WAS REMOVED AND REPLACED WITH A BACK-UP LENS (SAME MODEL, SAME DIOPTER) IN THE SAME PROCEDURE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION AND NO PATIENT INJURY. THE IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691492 ↗
• MalfunctionFeb 14, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS SHEERED OFF AND WAS OBSERVED AFTER IT WAS INSERTED INTO THE PATIENT'S LEFT EYE. THE LENS WAS REMOVED FROM THE EYE AND ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529770 ↗
• InjuryJan 4, 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 AS THE PATIENT COMPLAINED OF BLURRY VISION AND THERE WAS 1.17 HYPEROPIA. A COMPETITOR LENS WAS PLACED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTIONS WERE REQUIRED. THE PATIENT WAS REPORTEDLY DOING FINE ONE DAY POST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13161382 ↗