TECNIS IOL DXR00V (REF DXR00VU220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474761834), received between Sep 29, 2022 and Oct 24, 2024 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. 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.

• InjuryOct 24, 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 DUE TO HALOS AND GLARES. THERE WERE NO SUTURE OR VITRECTOMY DONE WITH THE EXCHANGE, OF THE LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20524286 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PLACEMENT OF A PRELOADED INTRAOCULAR LENS (IOL) TECNIS SIMPLICITY TECNIS SYMFONY, AN ANTERIOR VITRECTOMY WAS PERFORMED. IT WAS NOTED THAT THERE WAS PATIENT CONTACT. A DIFFERENT MODEL IOL WAS PLACED INTO PATIENT'S EYE AS REPLACEMENT AND THE ISSUE WAS RESOLVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 20072278 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT CANNOT SEE GOOD OUT OF BOTH EYES AND COMPLAINING OF BURNING SENSATION. 1ST PROCEDURE FOR RIGHT EYE (OD) WAS DONE ON (B)(6) 2022. THE PATIENT STATED THAT HER PHYSICIAN GAVE HER RESTASIS FOR THE BURNING IN BOTH EYES. THE PATIENT IS GOING TO SEE HER DOCTOR AGAIN BUT DOES NOT RECALL WHEN. THE PATIENT STATED THAT DURING THE IMPLANT OF OD, SHE HAD NO VISUAL CONCERNS. HOWEVER, AFTER THE LEFT EYE (OS) WAS IMPLANTED, THE VISUAL ISSUES OF BURNING SENSATION LEADING TO BLURRY VISION/CANNOT SEE WELL IN BOTH EYES HAPPENED. THERE WAS NO EYE REDNESS. THE PATIENT WENT TO HER IMPLANT DOCTOR WHO TOLD HER THAT HER NUMBERS WERE ALL GOOD. BUT HER DOCTOR GAVE HER REFRESH AND RESTASIS EYE DROPS, WHICH HELP WITH THE "EYE BURNING" THAT LED TO NOT SEEING CLEARLY. THE PATIENT REPORTED THAT SHE WAS STILL KIND OF ABLE TO READ, WATCH TV AND DRIVE BUT HAS TO BE WITH EYEGLASSES. THE PATIENT GOT SCARED OF DRIVING SINCE SHE HAD BEEN TO TWO ACCIDENTS ALREADY. FOR 2 1/2 WEEKS NOW, THE PATIENT HAS NOT BEEN DRIVING ANYMORE. THE PATIENT STATED THAT SHE IS GOING TO SEE ANOTHER DOCTOR SOON FOR 2ND OPINION. IN FOLLOW UP WITH THE DOCTOR, IT WAS STATED THAT THE PATIENT HAD YTTRIUM ALUMINUM GARNE

  Patient problems: Blurred Vision; Dry Eye(s); Eye Irritation

  MAUDE report 19236048 ↗
• MalfunctionJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE WEEK AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE, THE PATIENT¿S NEAR VISION WAS GOOD, BUT DISTANCE VISION OR OVERALL VISION WAS A BIT BLURRY. THE SURGEON NOTED THAT THE LENS LOOKED LIKE IT WAS NOT CENTERED ON THE PUPIL, SUCH THAT THE FIRST RING WAS VISIBLE. THE PATIENT WILL BE SEEN AGAIN FOR FOLLOW-UP ON (B)(6) 2023, AND THE SECOND EYE CATARACT SURGERY MAY BE DELAYED. THROUGH FOLLOW-UP WITH THE SALES REPRESENTATIVE, IT WAS LEARNED THAT THE PATIENT WAS SEEN BY THE SURGEON ON (B)(6) 2023, AND THE SURGEON REPORTED THAT THINGS WERE A LOT BETTER WITH THE PATIENT. THE PATIENT WAS NOW SEEING WELL, IS HAPPY WITH THE RESULTS, AND WANTS TO MOVE FORWARD WITH THE SECOND EYE CATARACT SURGERY. THE SALE REPRESENTATIVE REPORTED THAT THE SURGEON DID NOT MENTION THE POSITION OF THE LENS AGAIN, JUST THAT EVERYTHING WAS BETTER. THE LENS WAS NOT REPOSITIONED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE LENS REMAINS IMPLANTED.

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

  MAUDE report 18475825 ↗
• MalfunctionNov 8, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE LENS SEEMED TO HAVE A SMALL BLUE OBJECT ON IT WHEN IT WAS IMPLANTED. THE DOCTOR WAS ABLE TO REMOVE THE OBJECT AND DETERMINED THE LENS WAS SAFE TO STAY IMPLANTED. ADDITIONAL INFORMATION REVEALED THAT A BLUE FRAGMENT WAS REMOVED FROM THE LENS AND PLACED IN SALINE. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS IS REQUIRED AND PATIENT IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097213 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS), IS GOING TO BE EXPLANTED ON (B)(6) 2023 DUE TO EXCESSIVE GLARE. IT WILL BE REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (EYHANCE DIB00 MODEL). THROUGH FOLLOW-UP, IT WAS LEARNED THAT THAT BESIDES GLARE, THE PATIENT IS ALSO NOT HAPPY WITH THE VISUAL ACUITY (VA) IN THE OS. THE SYMPTOMS STARTED ON POST-OPERATIVE DAY ONE ((B)(6) 2023). THE PATIENT¿S PRE-OPERATIVE VA OS WAS UNCORRECTED DISTANCE (DSC) 20/50-1, CORRECTED DISTANCE (DCC) 20/25, NEAR UNCORRECTED (NSC) 20/70, NEAR CORRECTED (NCC) 20/30, BRIGHTNESS ACUITY TEST (BAT) 20/30. THE PATIENT'S POST-OPERATIVE VA POST-ORIGINAL IMPLANT IN OS WAS DSC 20/25 BLURRY, NSC J7 VERY BLURRY. IT IS UNKNOWN IF THE VISUAL ISSUES AFFECTED THE PATIENT'S DAILY ACTIVITIES. NO MEDICAL OR SURGICAL INTERVENTION FOR THIS ISSUE HAS BEEN PERFORMED YET. THE PATIENT IS AWAITING THE IOL EXCHANGE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE IOL EXCHANGE WAS PERFORMED ON (B)(6) 2023. THE IOL EXCHANGE SURGERY OPERATIVE REPORT WAS PROVIDED. THE PATIENT¿S PRE-OPERATIVE CHECKLIST REPORT FOR THE IOL EXCHANGE STATES THAT THE PATIENT WANTS NEAR

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

  MAUDE report 17971116 ↗
• MalfunctionOct 3, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT ONCE A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT¿S RIGHT EYE, THERE WAS A SCRATCH ON IT. THERE WAS PATIENT CONTACT AND THE LENS FULLY INSERTED. THE LENS WAS REMOVED, AND A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED DURING THE SAME PROCEDURE. THERE WAS A 10-MINUTE DELAY IN PROCEDURE AND THE INCISION WAS ENLARGED, BUT NO SUTURES USED, AND NO VITRECTOMY PERFORMED. NO ADDITIONAL SURGICAL AND OR MEDICAL INTERVENTIONS WERE PLANNED OR REQUIRED. THE PATIENT OUTCOME WAS GOOD, AND NO INJURY REPORTED. IT WAS INDICATED THAT A COMPETITOR¿S OPHTHALMIC VISCOELASTIC DEVICE (OVD) WAS USED, BUT NO COMBINATION OF BALANCED SALT SOLUTION (BSS) AND OVD AND THAT THE LUBRICANT USED WAS INTRODUCED INTO THE CARTRIDGE FROM CARTRIDGE CANOPY. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17865386 ↗
• InjuryMay 15, 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 THE PATIENT BEING UNHAPPY WITH NEAR VISION WITH THE IMPLANTED LENS AND REQUESTING THE SURGEON TO GIVE THE PATIENT BETTER NEAR VISION "10 PT". THE ISSUE WAS FIRST OBSERVED DURING A POST-OPERATIVE EXAMINATION. DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. SYMPTOMS PERSISTED FOR 2.5 MONTHS AND THERE WAS A 2.5 MONTH DELAY IN PROCEDURE. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT FOR GOAL (+24.0D). NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURE WAS REQUIRED. NO MEDICATION WAS PRESCRIBED OUTSIDE THE STANDARD OF CARE. DIRECTIONS FOR USE WERE FOLLOWED. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20 AND POST-OPERATIVE BSCVA WAS 20/20. NO PATIENT INJURY WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 16935851 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DXR00V INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DOCTOR STATED HE HAD A MISS ON THE POWER. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT IS EXPERIENCING BLURRY VISION AND HALOS AND THE BLURRY VISION IS DEBILITATING. DXR00V IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED IN THE PATIENT'S OD. LASIK ENHANCEMENT PROCEDURE WAS PERFORMED ON 25(B)(6) 2022. PATIENT OUTCOME WAS REPORTED AS: OD= 20/20, NEAR VISUAL ACUITY (VA) J2 ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 15507343 ↗