TECNIS IOL ZXR00 (REF ZXR00U0255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05050474579200), received between Dec 7, 2016 and Jan 14, 2022 — classified as 26 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AT A LATER DATE DUE TO ANISOMETROPIA, IOL MALPOSITION, AND BLURRY VISION NOTED DURING POST-OPERATIVE EXAMINATION. ACCOUNT PROVIDED VISUAL ACUITIES AS PRE-OPERATIVE 20/20- BEST CORRECTED: +225 +075 X 150, POST-OPERATIVE 20/20 BEST CORRECTED: -150 SPH. THERE WAS NO SUTURE(S) AND NO VITRECTOMY; HOWEVER, THE INCISION WAS ENLARGED. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 13261897 ↗
• InjuryApr 16, 2021Adverse 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 LEFT (OS) EYE DURING THE SECOND PROCEDURE DUE TO UNEXPECTED POST-OP REFRACTION. THE VISION PRE-OPERATIVE WAS 20/80 5C. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11678273 ↗
• InjuryDec 16, 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 RIGHT EYE DUE TO OFF TARGET AFTER CATARACT EXTRACTION. IT WAS LEARNED THAT THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. NO PATIENT POST-OP INJURY. THE SUSPECT IOL WAS REPLACED WITH THE SAME MODEL IOL BUT LOWER DIOPTER POWER (23.5). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 11016971 ↗
• InjuryNov 12, 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 A PATIENT'S LEFT EYE DUE TO EXTREME GLARE AND SYMPTOMS WERE DEBILITATING. AT EXPLANT THERE WAS AN INCISION ENLARGEMENT; HOWEVER, NO VITRECTOMY OR SUTURES WERE REQUIRED. A NON-JOHNSON & JOHNSON LENS OF 25.0 DIOPTER POWER WAS USED. THE PATIENT HAS EXCELLENT VISION AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10833546 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2020 AND EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINTS OF BLURRY VISION FROM 50FT OUT AND TERRIBLE GLARE AT NIGHT. THE REPLACEMENT IOL IS A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. IT WAS ALSO REPORTED THE EXPLANTED LENS IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10330819 ↗
• InjurySep 6, 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 EXPLANTED DUE TO THE PATIENT EXPERIENCING BLURRY VISION WHICH STARTED ON DAY ONE POST-OP. THE EXPLANTED IOL WAS REPLACED WITH A NON- JOHNSON AND JOHNSON IOL. THERE WAS NO REPORT OF INCISION ENLARGEMENT, VITRECTOMY OR SUTURES THAT WERE REQUIRED. THE PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8968356 ↗
• InjuryMay 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZXR00 25.5 DIOPTER WAS EXPLANTED DUE TO PATIENT'S BLURRED VISION. REPORTEDLY THE PATIENT WAS DISCOURAGED. THERE WERE NO SURGICAL INTERVENTIONS REQUIRED SUCH AS VITRECTOMY, INCISION ENLARGEMENT AND SUTURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. IT WAS INDICATED THAT THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8602243 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (ZXR00 +25.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) IN A SECONDARY PROCEDURE DUE TO HALOS. REPORTEDLY, A ZCB00 +26.0 WAS IMPLANTED AS A REPLACEMENT. NO VITRECTOMY WAS PERFORMED AND THE PATIENT WAS REPORTED BEING OKAY. IT WAS NOTED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8571940 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT WITH BILATERAL IMPLANT OF INTRAOCULAR LENSES (IOLS) THAT HE WAS EXPERIENCING BLURRED VISION, HALOS AND GLARE WHICH BEGAN SOON AFTER THE LENSES WERE IMPLANTED. THEY SYMPTOMS AFFECT HIS ABILITY TO DRIVE AT NIGHT. ADDITIONAL INFORMATION RECEIVED REVEALED THAT PATIENT HAS USED PRESCRIPTION AND OVER THE COUNTER (OTC) EYE DROPS TO TREAT DRY EYE ISSUES WHICH ALSO BEGAN AFTER THE IOLS WERE IMPLANTED. THE EYE DROPS DID NOT HELP ALLEVIATE THE DRY EYE AND HE HAS DISCONTINUED THERE USE. THE PATIENT REPORT HIS VISION IS GOOD BUT THE GLARE IS SEVERE. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR THE LEFT EYE (OS); A SEPARATE REPORT IS BEING SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8502352 ↗
• InjuryMar 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD COMPLICATIONS AFTER THE IMPLANTATION OF +25.5 DIOPTER LENS MODEL, ZXR00 SYMFONY MULTIFOCAL IOL (INTRAOCULAR LENS). FOR THAT REASON, LENS WAS EXPLANTED AND REPLACED WITH +24.5 DIOPTER LENS WITH THE SAME MODEL, ZXR00. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8468115 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED BLURRY VISION AND GLARE. ALSO NOTED, 2 NEAR POINTS NOT WITHIN COMFORT RANGE. THE PATIENT ALSO REPORTED THAT THESE ISSUES SIGNIFICANTLY AFFECT ACTIVITIES OF DAILY LIFE. THE BEST CORRECTED VISION FOR THE PATIENT WAS 20/40. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. THE REPLACEMENT LENS WAS A ZLB00 25.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8360310 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A ZXR00 INTRAOCULAR LENS (IOL) WHICH WAS LATER EXPLANTED DUE TO THE PATIENT EXPERIENCING DIOPTER POWER ISSUES. THE CUSTOMER ADDED THAT THEY DO NOT FEEL THAT THE SYMFONY IOL WAS TO BLAME. FOLLOW-UP CONFIRMED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR NO SUTURES PERFORMED. THERE WAS NO PATIENT INJURY POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8346340 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING POOR VISUAL ACUITY. REPORTEDLY THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8319245 ↗
• InjuryDec 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2018 IN THE PATIENT¿S LEFT EYE. THE PATIENT COMPLAINED OF BLURRED VISION AND DIFFICULTY DRIVING AT NIGHT. ADDITIONAL INFORMATION RECEIVED CONFIRMED AN EXPLANT TOOK PLACE ON (B)(6) 2018 AND THE REPLACEMENT LENS WAS 24.0 DIOPTER IOL. THE SURGEON STATED THERE WAS NOTHING WRONG WITH THE LENS, THE ISSUE WAS JUST A MATTER OF A REFRACTIVE MISS PROBABLY DUE TO BIOMETRY CHALLENGES DUE TO THE PATIENT¿S PRIOR REFRACTIVE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 8205391 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXR00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2018 AND EXPLANTED (B)(6) 2018 AND EXCHANGED FOR A ZXR00 27.5 DIOPTER IOL. THERE WAS NO REQUIRED MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8182716 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2018. THE LENS WAS EXPLANTED (B)(6) 2018 DUE TO A COMPLAINT OF ASTIGMATISM AFTER SURGERY. THE PATIENT CHOSE TO HAVE THE LENS EXCHANGED. THERE WAS NO INCISION ENLARGEMENT. IT WAS REPORTED THE PATIENT OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8110921 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH VISUAL ACUITY IN HER LEFT EYE (OS). SHE EXPERIENCED BLURRED DISTANCE VISION, HALOS & GLARE AROUND LIGHTS, ESPECIALLY AT NIGHT. THESE SYMPTOMS HAVE INTERFERED WITH HER REGULAR ACTIVITIES. THE LENS, A MODEL ZXR00 +25.5 WAS EXPLANTED ON (B)(6) 2018. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 7799595 ↗
• InjuryAug 17, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 25.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 24.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7795352 ↗
• InjuryApr 23, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 25.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO NEEDING A DIOPTER CHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7452065 ↗
• InjuryApr 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS ABOUT -2.0 DIOPTER POST-OPERATIVELY. THE REPLACEMENT LENS WAS A ZXR00 23.0 DIOPTER LENS. REPORTEDLY, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 7431534 ↗
• InjuryOct 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE OPERATIVE EYE OF THE PATIENT. IT WAS LATER EXPLANTED BECAUSE THE PATIENT COMPLAINED OF DECREASED VISION AND EVERYTHING WAS OUT OF FOCUS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6989079 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 25.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE ON (B)(6)2017 AND REPLACED WITH A NEW LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dry Eye(s); No Code Available; Visual Impairment

  MAUDE report 6850342 ↗
• InjuryAug 21, 2017Adverse 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), MODEL ZXR00 25.5 DIOPTER, WAS EXPLANTED FROM THE RIGHT EYE OF THE PATIENT ON (B)(6) 2017 DUE TO COMPLAINTS OF VISUAL ISSUES. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR POST-OPERATIVE INJURIES. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A LOWER DIOPTER SIZE (23.0). NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6806614 ↗
• InjuryMay 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO SYMFONY INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN THE EYES OF A (B)(6) YEAR-OLD FEMALE PATIENT DURING A BILATERAL SURGERY ON (B)(6) 2017. REPORTEDLY, A LITTLE OVER 2 MONTHS, POST-OP THE LENSES WERE GIVING A MYOPIC SHIFT. THE PATIENT¿S VISION WAS REPORTED BEING GREAT FOR NEAR AS SHE WAS OK WITH WORKING WITH THE COMPUTER AND READING; HOWEVER, THE DISTANCE VISION WAS BLURRY AND -2.75 OU (OCULUS UTERQUE - BOTH EYES). AS A RESULT OF FOLLOW UP ADDITIONAL INFORMATION WAS RECEIVED AND BOTH EYES ARE MYOPIC -2.00. THE SURGEON WOULD LIKE TO OFFER HER AN IOL EXCHANGE ON HER DOMINANT EYE (UNKNOWN WHICH EYE IS THE DOMINANT EYE). CURRENTLY THE SURGEON IS TRYING HER WITH A PAIR OF DISTANCE GLASSES. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR IS TO RECORD THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LENS IMPLANTED IN THE LEFT EYE.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6565323 ↗
• InjuryJan 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO POST REFRACTIVE ISSUE OR OVER MINUS ISSUE. LENS WAS REPLACED WITH THE SAME MODEL LENS, A 24.0 DIOPTER IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6239894 ↗