TECNIS IOL DFR00V (REF DFR00VU235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474750746), received between Sep 16, 2021 and Dec 8, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE OPERATIVE EYE, THE PATIENT EXPERIENCED SEVERE HALO AND GLARE. SUBSEQUENTLY, THE LENS WAS EXPLANTED IN A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. IT IS UNKNOWN IF ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED OR IF THERE WAS PATIENT HARM, AS NONE WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 23751377 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY, THE DOCTOR REPORTED THAT LOTS OF NIGHT GLARE WITH THE PATIENT'S LEFT (OS) EYE. IT WAS INDICATED THAT THE PATIENT'S UNCORRECTED VISUAL ACUITY ( UCVA ) IS 20/50, BEST CORRECTED VISUAL ACUITY (BCVA) IS +0.75 (VAGUE ENDPOINTS) ACHIEVING A POOR-QUALITY 20/30, AND SHE LOOKS OTHERWISE CLEAR, BUT THE DOCTOR HAD PLANNED TO LET THE LEFT EYE GO A BIT LONGER BEFORE DOING ANYTHING. THE PATIENT HAD NO LASIK HISTORY AND NO EVIDENT CORNEAL OR MACULAR PATHOLOGY. THE PATIENT ALSO DENIES AMBLYOPIA. ADDITIONAL INFORMATION RECEIVED FOR LEFT EYE ON (B)(6) 2024 INDICATED THAT OS VISUAL ISSUES DID NOT IMPROVE. THEY OBTAINED A SECOND OPINION AND THEY FOUND OS UCVA TO BE 20/25-, NEAR J5, AND A MANIFEST BCVA OF 20/20 WITH +1.75 SPHERE. THEY FOUND NO OTHER PATHOLOGY BESIDES A MILD CAPSULAR OPACITY. THE PATIENT IS GENERALLY HAPPY WITH RIGHT EYE (OD). THE DOCTOR FOUND OS BCVA 20/25 WITH +1.00+0.25X114. THERE WAS BETTER VISION DISTANCE AND NEAR WITH A +1.25 LOOSE LENS OVER THE PATIENT'S OS. THE PATIENT DECIDED TO UNDERGO OS LENS EXCHANGE ON (B)(6). THE EXPLANT WAS PERFORMED. THIS WAS REPLACED WITH THE SAME MODEL 2.0 DIOPTER POWER HIGHER THAN THE ORIGINAL IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITR

  Patient problems: Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 19356530 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD CATARACT PROCEDURE AND INTRAOCULAR LENS WAS IMPLANTED IN THE RIGHT EYE. ON DAY ONE POST OPERATIVE EXAMINATION ON (B)(6) 2023, PATIENT STATED THAT IT HURT WHEN SHE PUT THE DROPS AND THE NEAR VISION HAS NOT IMPROVED. THE PATIENT WAS ADVISED TO CONTINUE USING PREDNISOLONE/MOXIFLOXACIN FOUR TIMES A DAY. ON THE SECOND POST OPERATIVE VISIT ON (B)(6) 2023, PATIENT'S EYE WAS DOING WELL. PATIENT WAS DISAPPOINTED WITH THE HALOS AND RINGS AT NIGHT AND DIDN'T THINK THE READING WAS VERY GOOD WITH RIGHT EYE. ON THE THIRD POST OPERATIVE VISIT ON (B)(6) 2023, PATIENT STATED THAT SHE HAD DIFFICULTY WITH HALOS AT NIGHT AND BOTH COMPUTER DISTANCE AND READING WAS BLURRY. PATIENT WAS DISAPPOINTED WITH HALOING AND STARBURSTS. IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE DUE TO EXTREME DYSPHOTOPSIA AND REPLACED WITH ANOTHER MONOFOCAL OF A SLIGHTLY LOWER DIOPTER (23.0D) ON THE EXPLANT FIRST POST OPERATIVE VISIT (DAY 1 AFTER THE IMPLANT OF THE 23.0D LENS), THE PATIENT STATED THAT SHE COULD SEE DISTANCE FINE BUT CANNOT READ. THERE WAS NO PAIN OR DISCOMFORT. PATIENT WAS ADVISED TO CONTINUE THE MEDICATION PRESCRIBED EARLIER. NEXT DAY, P

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

  MAUDE report 16455678 ↗
• 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 RIGHT EYE DUE TO DYSPHOTOPSIA. IT WAS STATED THAT THERE WAS NO INCISION ENLARGEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 16392157 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING GLARE WITH BRIGHT LIGHTS AND BLURRED VISION AT BOTH DISTANCE AND NEAR IN THEIR RIGHT EYE (OD). THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AND A DIBOO 24.0D WAS IMPLANTED. THEY SWITCHED FROM A MULTIFOCAL LENS TO A MONOFOCAL IOL DUE TO DECREASED CONTRAST AND GLARE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S VISION READINGS WERE PROVIDED AS PRE-OPERATIVE DISTANCE (BEFORE THE EXCHANGE) VISUAL ACUITY (VA) 20/40 AND POST-OPERATIVE (AFTER THE EXCHANGE) DISTANCE VA 20/25; PRE-OPERATIVE (BEFORE THE EXCHANGE) NEAR VA 20/70 (BEST CORRECTED) AND POST-OPERATIVE (AFTER THE EXCHANGE) NEAR VA 20/20 (BEST CORRECTED). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15108387 ↗
• InjuryJun 16, 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 DUE TO THE PATIENT'S VISION WAS NOT SHARP AND PATIENT WAS EXPERIENCING HALOS AND GLARE. DURING THE EXPLANT, ONE SUTURE WAS NEEDED. ANOTHER JOHNSON & JOHNSON DFW150 LENS (DIFFERENT MODEL AND 23.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT OUTCOME REPORTED VISION IS EXCELLENT ALTHOUGH THERE ARE HALOS AT NIGHT. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14723496 ↗
• 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 RIGHT EYE BECAUSE THEY EXPERIENCED DEBILITATING RINGS AROUND LIGHT AT NIGHT. THE REPLACEMENT LENS WAS A NON-JOHNSON & JOHNSON LENS OF 22.5 DIOPTER. THERE WAS NO CAPSULE TEAR REPORTED, NO VITRECTOMY REQUIRED AND NO SUTURES WERE USED. THE PATIENT OUTCOME POS-OP IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 14283752 ↗
• MalfunctionApr 25, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING IMPLANTATION THE TRAILING HAPTIC OF THE PRE-LOADED INTRAOCULAR LENS (IOL) SHEARED OFF. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED STATING THE PRE-LOADED IOL WAS FULLY INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND NO VITRECTOMY. THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP LENS WITH THE SAME MODEL AND DIOPTER SIZE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196441 ↗
• InjuryApr 7, 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 (OS) EYE DUE TO HALOS AND GLARE. A NON-JOHNSON AND JOHNSON LENS WAS PLACED AS THE REPLACEMENT IOL. NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE EXTRACTED LENS WAS DESTROYED AFTER THE PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14048673 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED IN THE PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING POOR DISTANT VISION AND WAS BOTHERED BY HALOS. THERE WAS NO MEDICAL OR ADDITIONAL SURGICAL INTERVENTION REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 13895819 ↗
• InjuryDec 27, 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 REMOVED FROM THE OPERATIVE EYE DUE TO EXCESSIVE GLARE. FURTHER FOLLOW-UP REVEALED THAT THE REPLACEMENT LENS WAS A COMPETITOR LENS AND THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES DONE. PATIENT WAS REPORTEDLY DOING EXCELLENT POST-OPERATIVELY. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 13091138 ↗
• InjuryDec 9, 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 EXPERIENCING GLARE. A NON-JOHNSON AND JOHNSON IOL WAS USED AS THE REPLACEMENT LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES DONE. NO PATIENT POST-EXPLANT INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 12972933 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2-WEEK POST OPERATIVE POWER MISS (-2.0 DIOPTER MISS) WAS NOTICED WITH A SYNERGY INTRAOCULAR LENS (IOL). TARGET REFRACTION WAS THE FIRST PLUS AND THE PATIENT ENDED UP WITH -2 DIOPTER. IT WAS NOTED THAT THE SURGERY HAD ZERO COMPLICATIONS AND ALL THE PRE-OPERATIVE MEASUREMENTS WERE CONSISTENT. THE SURGEON DID EXPLAIN THE PATIENT¿S CAPSULAR BAG WAS EXTREMELY LARGE AND HE BELIEVES IT ATTRIBUTED TO THE MISSED EFFECTIVE LENS POSITION. THE PATIENT CAN PERFORM TASKS BUT MOST OF THE LENS FUNCTIONALITY IS MISSED DUE TO REFRACTIVE OUTCOME. REPORTEDLY, THE SURGEON DID COMPLETE A YTTRIUM-ALUMINUM-GARNET (YAG) LASER PROCEDURE AT ONE MONTH POST OP. IT WAS ALSO INDICATED THAT THE PATIENT IS SEEING ANOTHER SURGEON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12670472 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HALOS, GLARE AND EXTREME LIGHT SENSITIVITY AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO HER EYES. ACCORDING TO HER LAST POST-OPERATIVE EXAMINATION, THE DAILY ACTIVITIES HAVE BEEN AFFECTED DUE TO ISSUE. HOWEVER, NO EXPLANT HAS BEEN PLANNED OR PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE. THIS REPORT CAPTURES INFORMATION RELATED TO IOL IMPLANTED IN PATIENT RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED AGAINST THE IOL IMPLANTED IN LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12595465 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HALOS, GLARE AND EXTREME LIGHT SENSITIVITY AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL) INTO HER EYES. ACCORDING TO HER LAST POST-OPERATIVE EXAMINATION, THE DAILY ACTIVITIES HAVE BEEN AFFECTED DUE TO ISSUE. HOWEVER, NO EXPLANT HAS BEEN PLANNED OR PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE. THIS REPORT CAPTURES INFORMATION RELATED TO IOL IMPLANTED IN PATIENT LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED AGAINST THE IOL IMPLANTED IN RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12595463 ↗
• InjurySep 27, 2021Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DFR00V MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO MECHANICAL FAILURE. THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 12538249 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL SYNERGY INTRAOCULAR LENS (IOL) EXCHANGE DUE TO HALOS, COULDN¿T SEE STREET SIGNS, AND HALOS WERE BLINDING. THE PATIENT WAS 20/20 DISTANCE, 20/16 INTERMEDIATE, AND J1+ NEAR. THE REPLACEMENT IOLS WERE EYHANCE, AND THE PATIENT IS HAPPY. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE SUSPECT PRODUCT WITH SERIAL NUMBER (B)(4). A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER SUSPECT PRODUCT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12485764 ↗