TECNIS IOL ZXR00 (REF ZXR00U0230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 05050474579156), received between Dec 11, 2016 and Jan 29, 2024 — classified as 69 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (8 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 75 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA AND NIGHT GLARE. THERE WERE NO COMPLICATIONS SUCH AS VITRECTOMY, SUTURES, INCISION ENLARGEMENT OR DELAY IN THE PROCEDURE. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS REQUIRED. THE SYMPTOMS DID NOT IMPACT THE PATIENT¿S DAILY ACTIVITIES. THE PATIENT HAS FULLY RECOVERED. THE CUSTOMER INDICATED THAT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 18603692 ↗
• InjuryJun 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 IN A SECONDARY PROCEDURE DUE TO GLARE. ANOTHER JOHNSON AND JOHNSON LENS WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIB00, DIFFERENT DIOPTER, 24.5). THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING GREAT POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17121075 ↗
• InjuryDec 13, 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 IMPLANTED IN A PATIENT'S LEFT EYE. AFTER SURGERY (NO SPECIFIC DATE PROVIDED) THE PATIENT'S WAS BLURRY AND LATER ON VISUAL ISSUES BECAME MORE BLURRY THEN WITH GLARE AND FLOATERS BECOMING WORSE. THE PATIENT STILL GOES TO WORK IN A CHILD CARE FACILITY BUT HAS TO ADJUST THINGS SINCE SHE CANNOT BE ABLE TO DRIVE AT NIGHT ANYMORE. THE PATIENT WAS PRESCRIBED GLASSES WHICH SHE DID NOT MIND BUT HER ISSUE IS THE NOT BEING ABLE TO DRIVE AT NIGHT. SHE FEELS TERRIBLE AND IS TRULY AN UNHAPPY CAMPER. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 15974572 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF HALOS AND GLARE, OPTED FOR INTRAOCULAR LENS (IOL) TO BE REMOVED FROM THE RIGHT EYE. THE LENS WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 IOL, BUT SAME DIOPTER SIZE. IT WAS STATED THAT INCISION WAS NOT ENLARGED AND THAT THE PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15048566 ↗
• InjuryJun 21, 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 EYE DUE TO HALOS AND GLARE. ACCOUNT INDICATED THAT THE SYMPTOMS INTERFERED WITH PATIENT'S ABILITY TO PERFORM ACTIVITIES OF DAILY LIFE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF DIFFERENT MODEL AND OF LOWER DIOPTER. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14758252 ↗
• InjuryJan 19, 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 IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT COMPLAINT OF SEEING HALOS ALL THE TIME. A REPLACEMENT LENS OF DIFFERENT MODEL DIB00 (+21.5 D) WAS USED. THERE WERE NO MEDICAL/SURGICAL INTERVENTIONS REQUIRED AND NO DELAY WAS REPORTED. PATIENT OUTCOME WAS REPORTED TO BE UNKNOWN AS THE PATIENT WENT BACK TO REFERRING DOCTOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 13296516 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON EXPLANTED AN INTRAOCULAR LENS (IOL) FROM THE PATIENT'S OPERATIVE EYE DUE TO COMPLAINT OF VISION BY POWER IMPLANTED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND UNKNOWN DIOPTER) WAS IMPLANTED AS A REPLACEMENT. SURGEON HAS NO ISSUES WITH LENS OTHER THAN ISSUE WITH PATIENT COMPLAINT OF VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 13216898 ↗
• 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 RIGHT EYE DUE TO BLURRY VISION AND VISUAL DISTURBANCE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12966199 ↗
• MalfunctionOct 26, 2021Use of Device Problem; Scratched Material; Use of Device Problem; Scratched Material

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS SCRATCHED AS IT WAS PLACED INTO THE CARTRIDGE, THERE WAS A LOADING ERROR, AND THERE WAS PATIENT CONTACT. PROCEDURE WAS COMPLETED USING ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO MEDICAL AND NO SURGICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12700214 ↗
• InjuryAug 24, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CUSTOMER IS LOOKING FOR SOME GUIDANCE ON WHAT MIGHT BE CAUSING THE POST-OP (OPERATIVE) MISS IN AN "OFF-LABEL" CASE. THE PATIENT HAD UNEXPECTED RESIDUAL REFRACTIVE ERROR AFTER A BILATERAL SYMFONY IMPLANTATION. THE DOCTOR ALSO PATIENT ALSO REPORTED THE PATIENT HAS DYSPHOTOPSIA, THEREFORE, THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE LEFT EYE. THE LENS WAS DISCARDED. THE LENS WAS REPLACED WITH EYHANCE IOL, SERIAL NUMBER IS UNKNOWN. PRIOR TO REFRACTIVE LENS EXCHANGE (RLE): RIGHT EYE (OD) +1.50 DS; LEFT EYE (OS) +1.25-0.50X045. POST RLE: OD -1.50-0.25X135. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE SUSPECT PRODUCT FOR THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE SUSPECT PRODUCT.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12360125 ↗
• InjuryApr 19, 2021Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  RECEIVED REPORT INDICATING THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO MECHANICAL FAILURE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11690957 ↗
• InjuryMar 18, 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 DUE TO MECHANICAL COMPLICATIONS PRODUCT ISSUE. THE SUSPECT IOL WAS REPLACED WITH A DIFFERENT MODEL HIGHER DIOPTER POWER LENS. IT WAS LEARNED THAT BY MECHANICAL COMPLICATIONS PF PRODUCT MEANT THAT THE PATIENT COMPLAINED FROM THE BEGINNING THAT SHE HAS BEEN UNABLE TO SEE MUSIC BOOKS TO PLAY HER PIANO. SHE HAS BEEN VERY UNHAPPY FROM THE ORIGINAL IMPLANT. SHE IS A PHYSICIAN AND SHE HAS DIFFICULTY SEEING CHARTS AND COMPUTER IN THE WAY SHE THOUGHT THE LENS WOULD GIVE HER. THEREFORE, THE IOL EXPLANT WAS DONE. IT DOES NOT APPEAR AN ENLARGED INCISION WAS NEEDED DURING EXPLANT OR ANY OTHER COMPLICATIONS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11520652 ↗
• InjuryAug 24, 2020Adverse 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 A MECHANICAL COMPLICATION/ REFRACTIVE MISS-VISUAL ACUITY. AN INCISION ENLARGEMENT WAS REQUIRED AND SUTURES WERE PLACED. INFORMATION FOR THE REPLACEMENT LENS WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10446082 ↗
• InjuryAug 12, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THERE WAS LOADING ISSUE, HANDLING PROBLEM/USE ERROR WITH AN INTRAOCULAR LENS (IOL) AND THE LENS WAS PARTIALLY INSERTED INTO THE PATIENT'S LEFT EYE. THERE WAS A CAPSULE TEAR AND VITRECTOMY WAS PERFORMED. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. IT WAS INDICATED THAT THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10398906 ↗
• InjuryMay 4, 2020Adverse 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 APPROXIMATELY 2-3 MONTHS AGO BY ANOTHER SURGEON BECAUSE OF EXTREME GLARE OR INABILITY TO DRIVE, PARTICULARLY AT NIGHT. ADDITIONAL INFORMATION STATES THERE WAS NO MEDICAL/ SURGICAL INTERVENTION POST-EXPLANT AND NO PATIENT INJURY. ANOTHER LENS WAS IMPLANTED AS REPLACEMENT. PATIENT IS HAPPY AND SYMPTOM FREE POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10020756 ↗
• InjuryMar 12, 2020Adverse 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 +23.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT (OS) EYE BECAUSE OF PATIENT EXPERIENCING BLURRY/WAXY VISION. REPORTEDLY A LENS FROM ANOTHER MANUFACTURER WITH SAME DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. INCISION ENLARGEMENT WAS PERFORMED AND SUTURES WERE REQUIRED DURING THE PROCEDURE. VISUAL ACUITY PRE-OP WAS 20/20. THE DEVICE HAS BEEN DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9824239 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT INJURY. NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY OR INCISION ENLARGEMENT WERE REQUIRED. THE REPLACEMENT LENS USED IS AN ALCON LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9723187 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED BILATERAL LENS EXPLANTS OF TECNIS SYMFONY INTRAOCULAR LENSES (IOL), MODEL ZXR00 DUE TO THE FEMALE PATIENT EXPERIENCING DISABLING HALOS AND GLARE. SYMPTOMS WERE FIRST NOTED IMMEDIATELY POST-OP FOR BOTH EYES. IT WAS INDICATED AT EXPLANT THAT THE INCISION WAS ENLARGED TO REMOVE THE IOL AND SUTURES WERE REQUIRED. A REPLACEMENT LENS, MODEL ZCB00 24.5 DIOPTER WAS USED. NO OTHER SURGICAL/MEDICAL INTERVENTIONS WERE REPORTED. THE PATIENT'S OUTCOME WAS REPORTED TO BE FAVORABLE, STABLE AFTER THE IOL EXCHANGES AND THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE LENSES ARE AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED. VISUAL ACUITY PRE-OP 20/70; 20/60, VISUAL ACUITY POST-OP 20/20; 20/25. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Halo; No Code Available

  MAUDE report 9635385 ↗
• InjuryNov 26, 2019Adverse 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 DUE TO POOR VISION. THE LENS WAS REPLACED WITH A MODEL ZCB00, A 23.0 DIOPTER. PATIENT WAS REPORTED DOING GREAT POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9376162 ↗
• InjuryOct 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 IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED DUE TO HALO AND GLARE. THE SURGEON INDICATED THAT THE LENS HAS BEEN CUT INTO PIECES AND IS NOT BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9227630 ↗
• InjurySep 9, 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 IN A PATIENT¿S LEFT EYE (OS) BUT THE PATIENT IS UNHAPPY WITH HER VISION AS IT IS BLURRY AND UNSTABLE. SHE REQUESTED EXPLANT OF BOTH LENSES AND REPLACED WITH A MONOFOCAL IOLS. IT WAS LEARNT THAT BOTH LENSES REMAIN IMPLANTED AND THAT THE PATIENT IS STILL DISSATISFIED. THE PATIENT STILL HAS BLURRY VISION, DESCRIBED AS NOT SEEING CLEARLY. THE PATIENT HAS A ZXR00 ON OS AND A ZLB00 ON OD. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8974685 ↗
• 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 RIGHT EYE. THE IOL WAS EXPLANTED DUE TO UNEXPECTED POST-OP VISUAL SURPRISE. THE REPLACEMENT LENS WAS THE SAME MODEL BUT DIFFERENT DIOPTER (21.5). 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 8844522 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00, 23.0 DIOPTER, INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN EXPLANTED DUE TO INTRAOCULAR POWER MISS. IT WAS LEARNT THAT SUTURES WERE PLACED, HOWEVER NO INCISION ENLARGEMENT AND NO VITRECTOMY WAS REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. THE EXPLANTED LENS WAS REPLACED WITH THE SAME MODEL BUT A LOWER DIOPTER (21.0). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8737710 ↗
• InjuryJun 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE LENS MALFUNCTIONED. REPORTEDLY, THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS, SAME MODEL AND A 22.0 (SMALLER) DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL. THE CUSTOMER WAS UNABLE TO PROVIDE ANY MORE INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8684427 ↗
• InjuryJun 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE LENS MALFUNCTIONED. REPORTEDLY, THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL. THE CUSTOMER WAS UNABLE TO PROVIDE ANY MORE INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8681026 ↗