TECNIS IOL ZXR00 (REF ZXR00U0180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 05050474579057), received between Jan 13, 2017 and Nov 22, 2022 — classified as 41 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 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 RIGHT EYE DUE TO THE PATIENT NOT SEEING WELL WITH THE SYMFONY EVEN WITH CORRECTION FOR ASTIGMATISM. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZCU. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15841603 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) MODEL NAME SYMFONY (ZXR00) WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON LENS, MODEL DFR00V (SYNERGY IOL). THE EXPLANTING DOCTOR INDICATED THEY ARE NOT THE ORIGINAL SURGEON. HE EXPLANTED THE SYMFONY AND IMPLANTED A SYNERGY IOL TO GIVE PATIENT THE NEAR VISION SHE DESIRED. THERE WAS NO CAPSULE TEAR. REPORTEDLY, THE EXPLANTED IOL WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED. THE CUSTOMER INDICATED THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 15188934 ↗
• InjuryMar 3, 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 LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO DYSPHOTOPSIA. A NON-JOHNSON & JOHNSON LENS WAS USED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 13664706 ↗
• InjuryNov 16, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO HAVING DECREASE VISION AND A SMUDGE IN THE CENTER OF THE EYE. THE LENS HAS BEEN DISCARDED. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTION REQUIRED. THE SURGERY WAS COMPLETED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 12818238 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPLANTED AN INTRAOCULAR LENS (IOL) DUE TO INSUFFICIENT NEAR VISION WITH ANISOMETROPIA; REFRACTIVE ERROR. THE SUSPECT PRODUCT WAS REPLACED WITH A DIFFERENT MODEL LENS AND DIOPTER,17.5D, WITH SERIAL NUMBER (SN) (B)(4). NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE DONE WITH THE EXPLANT. PATIENT IS DOING WELL NOW AND HAPPY WITH VISION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 12807862 ↗
• InjurySep 16, 2021Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) AND THE TRAILING HAPTIC WAS MESSED UP, BENT AND SUBSEQUENTLY FOLDED THEN BROKE. THE DOCTOR COULD NOT FIX THE HAPTIC AND THE LENS WAS CUT OUT. ANOTHER JOHNSON & JOHNSON SURGICAL VISION (JJSV) LENS WITH THE SAME MODEL AND DIOPTER SIZE WAS IMPLANTED WITHOUT DIFFICULTY. REPORTEDLY, THERE WAS BLEEDING CAUSED BY MANEUVERS PERFORMED TO EXTRACT THE LENS. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY AND BALANCED SALT SOLUTION (BSS) TAMPONADE WAS USED TO CONTROL BLEEDING. THERE WAS NO CAPSULE DAMAGE REPORTED. PATIENT HAD NO PRE-EXISTING EYE OR HEALTH CONDITIONS AND THEIR OUTCOME POST-PROCEDURE WAS REPORTED TO BE GOOD. THE IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485748 ↗
• InjuryNov 22, 2019Adverse 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 AS THE PATIENT COMPLAINED OF INTOLERABLE WAVY VISION. ANOTHER LENS (DIFFERENT MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9366682 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE, DUE TO VISUAL CONFUSION/HALOS/GLARE/BLUR. THE PATIENT HAD DIFFICULTY WITH VISION QUALITY AFTER THE SYMFONY LENS IMPLANT. THE LENS WAS REPLACED WITH A MODEL ZCB00, 18.0 DIOPTER LENS. NO FURTHER INFORMATION WAS AVAILABLE/PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9360135 ↗
• MalfunctionOct 3, 2019Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE LENS WAS NOT IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9151305 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE AND WAS THEN EXCHANGED FOR ANOTHER IOL OF THE SAME MODEL BUT DIFFERENT DIOPTER. THE EXCHANGE WAS PERFORMED BECAUSE THE PATIENT WAS UNHAPPY WITH THE ORIGINAL RESULTS. THERE WAS NO FURTHER INTERVENTION PERFORMED AND THE PATIENT WAS DOING VERY WELL POST-OPERATIVELY. REQUESTS FOR ADDITIONAL INFORMATION WERE NOT RETURNED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8952812 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS REMOVED DUE TO DYSPHOTOPSIA. IT WAS REPLACED WITH A ZCB00 IOL. THERE WAS NO INCISION ENLARGEMENT. THE PATIENT IS DOING FINE, NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8926766 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS LEFT EYE. THE IOL WAS EXPLANTED AS THE PATIENT NEEDED A DIFFERENT POWER. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND DIOPTER. THE PATIENT WENT FROM A MULTIFOCAL TO A NON-MULTIFOCAL IOL. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8844534 ↗
• InjuryJun 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A ZXR00 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER REMOVED ON (B)(6) 2018 DUE TO UNSPECIFIED LENS MALFUNCTION. THE EXPLANTED LENS WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURE REQUIRED. REPORTEDLY, PATIENT IS DOING WELL POST OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8684171 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 18.0 DIOPTER INTRAOCULAR LENSES (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2018. THE IOL WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH A ZCB00 IOL DUE TO COMPLAINTS OF THE PATIENT HAVING NOTHING BUT PROBLEMS WITH THE IOL AS IT IS NOT WORKING FOR HER. THE PATIENT IS POST LASIK AND CALCULATIONS SEEMED CORRECT. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CLARIFYING IOL REPORTED PROBLEMS AS POOR QUALITY VISION. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, AND THE EXPLANT WAS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8360814 ↗
• MalfunctionFeb 6, 2019Break; Break

  IT WAS REPORTED THAT A ZXR00, 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. IT WAS ALSO NOTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8309186 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXR00 18.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING GLARE. A MODEL ZCB00 18.5 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY REQUIRED. PATIENT IS DOING WELL POST EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8204630 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT COMPLAINED OF GLARE AND HALO. THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES USED, BUT A VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Vitrectomy

  MAUDE report 8183088 ↗
• InjurySep 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT REPORTED THAT IN THE YEAR OR SO SINCE RECEIVING THE ZXR00, TECNIS SYMFONY INTRAOCULAR LENS IMPLANTS, HE HAS STRUGGLED WITH VISION PROBLEMS, INCLUDING FOCUS, GLARE, STARBURSTS/SPIDERWEBS AND HALOS. NIGHTTIME DRIVING IS THE WORST FOR THE PATIENT AND THE PATIENT HAS TO WEAR READING GLASSES DUE TO COMPROMISED VISION. THE NEAR VISION TO A CERTAIN DISTANCE HAS IMPROVED, BEYOND THAT THE PATIENT IS DISAPPOINTED WITH THE RESULTS. AND WHEN THE DIFFERENT FORMS OF GLARE AND DISTRACTIONS ARE FACTORED IN, TO THE PATIENT IT IS APPARENT THESE LENSES ARE NOT DELIVERING WHAT HE EXPECTED. THE PATIENT HAS EXPRESSED HIS FRUSTRATION WITH THE LENSES WITH HIS DOCTORS FROM THE BEGINNING AND WAS TOLD TO GIVE IT TIME TO GET USED TO THEM, THAT HIS BRAIN WOULD SOMEHOW ADJUST. WHEN THAT FAILED, HE WAS GIVEN A PRESCRIPTION FOR DISTANCE GLASSES AND WAS TOLD THEY WOULD IMPROVE HIS VISION AS WELL AS REDUCE THE GLARE, WHICH ACCORDING TO THE PATIENT THAT DID NOT HELP GLARE AND STARBURST/HALO WISE, ALTHOUGH IT IMPROVED FOCUS. THE PATIENT HAD THE YTTRIUM-ALUMINUM GARNET (YAG) PROCEDURES ON BOTH EYES IN (B)(6) 2017, BUT IT DID NOT HELP RESOLVE HIS SYMPTOMS. THE PATIENT FEELS THAT HE IS NOW LEFT WITH QUEST

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 7921456 ↗
• InjuryAug 27, 2018Failure to Fold; Difficult to Insert; Material Split, Cut or Torn; Failure to Fold; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +18.0 DIOPTER) HAD LOADING ISSUES, FOLDING ISSUES AND A CRACK IN THE LENS. THE REPORTED EVENT WAS OBSERVED AFTER INSERTION INTO THE EYE. THE LENS WAS REMOVED USING DUET FORCEPS. REPORTEDLY, THE INCISION WAS ENLARGED DURING THIS PROCEDURE. ANOTHER LENS, SAME MODEL AND SIZE WAS USED AS THE REPLACEMENT FOR THE PATIENT. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7816020 ↗
• InjuryJul 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT HAD BILATERAL SYMFONY INTRAOCULAR LENS (IOL) IMPLANTS. (RIGHT EYE: ZXR00 +17.0 DIOPTER ON (B)(6) 2017 - LEFT EYE: ZXR00 +18.0 DIOPTER ON (B)(6) 2018). ONE-MONTH AFTER THE IMPLANTATION OF THE IOL INTO THE LEFT EYE, THE PATIENT HAD INFLAMMATION AFTER WEANING OFF HER DROPS. SHE WAS THEN STARTED ON ANOTHER PREDNISOLONE WEAN. SINCE THEN, SHE HAS HAD A MILD 1-2+ CELL RECURRENT UVEITIS, AND SHE WAS ON A SLOW (EVERY 2 WEEKS) DUREZOL WEAN. SHE ALSO DEVELOPED UVEITIS IN THE RIGHT EYE AFTER DOING A YAG (YTTRIUM ALUMINIUM GARNET) CAPSULOTOMY IN (B)(6) 2018, AND SHE STARTED SLOW DUREZOL WEAN ALSO IN THE RIGHT EYE. THE SURGEON COMMENTED THAT THERE WAS NOTHING SPECIAL ABOUT HER POSTERIOR CAPSULE OPACIFICATION. IT DIDN'T APPEAR LIKE A CHRONIC ENDOPHTHALMITIS, AND THE LEFT POSTERIOR CAPSULE WAS CLEAR. SHE HAS NO HISTORY OF UVEITIS PRIOR TO PHACO, AND HER UVEITIS LABS AND CHEST X-RAY ARE NORMAL. THE PATIENT COMPLAINS OF HAZY VISION, PAIN AND GLARE. WITHOUT THE DUREZOL, SHE CANNOT OPEN HER EYES DUE TO THE PHOTOPHOBIA. HER VISION IS GREAT WHEN THE UVEITIS IS CALM. THIS REPORT IS TO RECORD THE LENS IMPLANTED IN THE LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE

  Patient problems: No Code Available; Uveitis

  MAUDE report 7711806 ↗
• InjuryMay 31, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 18.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT''S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO VISUAL DISTURBANCES AND WAS REPLACED WITH THE SAME LENS MODEL, BUT DIFFERENT DIOPTER OF 16.5. REPORTEDLY, THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7556907 ↗
• MalfunctionMay 25, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT A ZXR00 18.0 DIOPTER LENS TORE WHEN THE PATIENT MOVED DURING INSERTION. THE DOCTOR REMOVED THE INSERTION SYSTEM FROM THE PATIENT'S EYE AND NOTED THE LENS HAD RIPPED. THERE WAS NO ADVERSE EFFECT, INJURY OR SURGICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7546654 ↗
• InjuryMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +18.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE. THE REASON FOR EXPLANT WAS NOT PROVIDED. ANOTHER MANUFACTURER'S LENS WAS USED AS A REPLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7513224 ↗
• InjuryMay 11, 2018Expulsion; Expulsion

  IT WAS REPORTED THAT A ZXR00 18.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF PATIENT COMPLAINTS OF EXCESSIVE HALOS, GLARE, AND STARBURSTS. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO PATIENT INJURY AND THE PATIENT STATES THAT THE HALOS AND GLARE ARE ''BETTER'' AFTER THE EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7506926 ↗
• InjuryMay 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +18.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION. REPORTEDLY A TORIC LENS WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7491649 ↗