TECNIS IOL DFR00V (REF DFR00VU120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474750517), received between Feb 27, 2022 and Nov 21, 2023 — classified as 6 injuries, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Break; Failure to Align; Mechanical Jam; Ejection Problem; Break; Failure to Align; Mechanical Jam; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WOULD NOT BUDGE WHEN ADVANCED. THE OPTIC OF THE LENS WAS CRACKED, TWISTED. THE LENS AND PLUNGER TIP WAS TORQUING TO THE SIDE. THE TIP OF THE CARTRIDGE WAS NOT DAMAGED. THE ISSUE WAS NOT DUE TO USE ERROR. THE LENS WAS PARTIALLY INSERTED IN THE EYE. A BACK-UP LENS WAS AVAILABLE AND WAS IMPLANTED WITH NO DIFFICULTY. THERE WAS A MINOR FIVE MINUTE DELAY IN SURGERY, BUT NO COMPLICATIONS OR INJURY TO PATIENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NON-JOHNSON AND JOHNSON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS USED AS A CARTRIDGE LUBRICANT, WHICH WAS INTRODUCED FROM THE CARTRIDGE CANOPY. THE AVERAGE DWELL TIME WAS TWO TO THREE MINUTES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181869 ↗
• MalfunctionOct 7, 2023Break; Break

  DOCTOR STATED, AS YOU KNOW, THE INTRAOCULAR LENS (IOL) COMES ALREADY LOADED IN ITS INJECTOR. THE TECHNICIAN THAT WAS WORKING WITH ME ON THE CASE, IS VERY GOOD AND A VERY EXPERIENCED TECHNICIAN. THE VISCOELASTIC WAS NOT ADDED TO THE INJECTOR UNTIL THE LENS IMPLANT POWER HAD BEEN CONFIRMED WITH THE OCULAR RESPONSE ANALYZER (ORA). AFTER THE LENS IMPLANT UNFOLDED, DOCTOR NOTICED THAT THERE WAS A SMALL CRACK IN THE OPTIC OF THE IOL. IT WAS SMALL AND LOCATED A FEW RINGS AWAY FROM THE CENTRAL RING, AND DETERMINED THAT IT WOULD NOT CAUSE A PROBLEM WITH THE PATIENT'S VISION. DOCTOR FELT THAT THE RISK OF REMOVING THE LENS IMPLANT OUTWEIGHED ANY POTENTIAL PROBLEM THAT THE CRACK MIGHT CAUSE. THEREFORE, THE LENS WAS LEFT IMPLANTED IN ITS PROPER POSITION IN THE CAPSULAR BAG. DOCTOR REPORTED THAT ON THE NEXT POSTOPERATIVE DAY THE PATIENT WAS DOING WELL AND HAD NOT EXAMINED THE PATIENT SINCE THEN. DOCTOR CLARIFIED THAT THE LENS IMPLANT WAS A LOW-POWER IOL +12.0 DIOPTER, SO HE DOES NOT THINK THE THICKNESS OF THE OPTIC WAS A CONTRIBUTING CAUSE OF THE CRACK. DOCTOR THINKS THAT IT MUST HAVE BEEN RELATED TO A PROBLEM WITH THE INJECTOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892516 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF POOR QUALITY OF NEAR AND DISTANCE VISION AND VISUALLY SIGNIFICANT HALOS AROUND LIGHTS; THE EXPLANTED IOL WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 12.0 DIOPTER IOL. THE PATIENT DID NOT HAVE ANY PRE-EXISTING MEDICAL CONDITION RELATED TO THE EYE. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO PRESCRIPTION WAS GIVEN OUTSIDE OF THE NORMAL POST-OPERATIVE TREATMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS 20/20 DISTANCE AND SYMPTOMS RESOLVED. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Halo

  MAUDE report 17446822 ↗
• InjuryJan 13, 2023Adverse 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 HAZY VISION. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME DIOPTER +12.0). THERE WAS NO PATIENT INJURY. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING BETTER POST-OPERATIVELY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 16163813 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR HAD TO EXPLANT A SYNERGY INTRAOCULAR LENS (IOL) FROM THE PATIENT'S RIGHT EYE DUE TO POOR HAZY VISION. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON LENS OF +12.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE. THE EXPLANTED LENS HAS BEEN DESTROYED AND NOT RETURNING. PATIENT OUTCOME IS BETTER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15978998 ↗
• InjuryNov 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO LENS DISLOCATED. THE IOL WAS REPLACED WITH A MONOFOCAL LENS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT WHEN THE IOL WAS OBSERVED DECENTERED IN THE RIGHT EYE, A FAR NASAL POSTERIOR CAPSULAR (PC) RENT WAS NOTED AND WAS NOT DETECTED AT THE TIME OF THE INITIAL SURGERY. A NON-JOHNSON & JOHNSON LENS WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. A VITRECTOMY AND SUTURES WERE REQUIRED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE ORIGINAL IOL WAS DISCARDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 15728501 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HAZY, GLARE, DAY DRIVING, AND "VASELINE SMUDGE" IN THEIR LEFT EYE (OS) WITH AN INTRAOCULAR LENS (IOL). THE PATIENT IS UNABLE TO SEE WITH THE CAMERA OR SEE TO EDIT PICTURES. THEREFORE, THE LENS WAS EXPLANTED. IT WAS REPORTED PATIENT HAD WAXY DISTANCE VISION. THE OSI (OBJECTIVE SCATTER INDEX) WAS HIGH POST-OP (GENERALLY >3). PATIENT MAINTAINS GOOD J1 NEAR ACUITY AND GOOD QUALITY OF VISION NEAR. THE PATIENT'S PRE-OPERATIVE (OP) VISUAL ACUITY WAS COUNTING FINGERS (CF) 3 FEET 20/20 AND POST-OP UNCORRECTED 20/20 -2 AND BEST CORRECTED VISUAL ACUITY 20/20. THE INTENDED TARGET WAS -0.24 SE (SPHERICAL EQUIVALENCE). THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED IN THE PATIENT'S EYE. PATIENT IS STATED TO BE VERY HAPPY POST-OPERATION. THE IOL WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15602235 ↗
• MalfunctionMay 24, 2022Scratched Material; Scratched Material

  REPORT OF AN INTRAOCULAR LENS (IOL) BEING FULLY INSERTED THEN REMOVED FROM THE PATIENT'S RIGHT EYE DUE TO SCRATCH ON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14482469 ↗
• InjuryFeb 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED PATIENT IS COMPLAINING OF SEVERE NIGHTTIME HALO WITH AN INTRAOCULAR LENS (IOL). SURGEON PLANNED ON DOING A LENS EXCHANGE. THROUGH FOLLOW-UP, WHEN THE PATIENT HAD THE SYNERGY IOL, THE PATIENT WAS 20/20 UNCORRECTED AT ALL DISTANCES (DISTANCE, INTERMEDIATE AND READING). THERE WAS NO RESIDUAL REFRACTIVE ERROR, BUT THE PATIENT WAS NOT ABLE TO DRIVE AT NIGHT BECAUSE OF TOO MANY HALOS THAT DID NOT MAKE HER FEEL SAFE. THEREFORE, THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. AFTER AN UNCOMPLICATED IOL EXCHANGE WITH ANOTHER JOHNSON & JOHNSON DIB00 LENS (DIFFERENT MODEL AND HIGHER DIOPTER), MOST OF THE PATIENT¿S SYMPTOMS WERE RESOLVED AND THE PATIENT FELT THAT SHE COULD NOW DRIVE AT NIGHT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 13615977 ↗