TECNIS IOL ZXT300 (REF ZXT300U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474606340), received between Jun 30, 2017 and Nov 18, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Arcing” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO IOL INTOLERANCE BECAUSE OF STARBURST AND GLARE. REPLACEMENT LENS WAS A ZCU MODEL OF THE SAME DIOPTER, SERIAL NUMBER (B)(4). THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT IS DOING WELL AND NO INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 12838750 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL SUBJECT RETURNED FOR 6 MONTH VISIT. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/25 RIGHT EYE (OD), 20/20 LEFT EYE (OS); BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/20 BOTH EYES (OU). ON THE QUESTIONNAIRE, THE SUBJECT NOTED AS VERY BOTHERED BY STARBURSTS WHILE DRIVING AT NIGHT. NO PLANS FOR SURGICAL INTERVENTION AT THIS TIME. FOLLOW-UP CONFIRMED THAT THE SUBJECT STATED THE STARBURSTS IN PARTICULAR ARE DEBILITATING. HE DESCRIBED THEM AS SEVERE AND STATED THAT HE IS UNABLE TO DRIVE AT NIGHT DUE TO THE STARBURSTS. THE DOCTOR DISCUSSED LENS EXCHANGE AND YTTRIUM ALUMINUM GARNET (YAG) WITH PATIENT TO TRY TO RELIEVE THESE SYMPTOMS. PATIENT IS SCHEDULED FOR A YAG EVALUATION ON (B)(6) 2021 TO DETERMINE IF THIS IS THE OPTION HE WILL PROCEED WITH. UNSCHEDULED VISIT NOTED UCDVA 20/25 OU; BCDVA 20/15 OD, 20/20 OS. ON THE QUESTIONNAIRE, THE SUBJECT COMPLAINED BEING VERY BOTHERED BY HALOS WHILE DRIVING AT NIGHT; VERY BOTHERED BY STARBURSTS WHILE DRIVING AT NIGHT AND VERY BOTHERED BY GLARE WHILE DRIVING AND WATCHING TV. NO PLANS FOR INTERVENTION AT THIS TIME. MONTH 1 VISIT NOTED VISUAL ACUITY UCDVA 20/20 OU AND BCDVA 20/15 OU. THE FOLLOWING COMPLAINT WAS REPOR

  Patient problems: Flashers; Halo

  MAUDE report 12587248 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICAL STUDY PATIENT UNDERWENT BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. AT 1 MONTH VISIT HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS VERY BOTHERED BY HALOS, VERY DISTRACTIVE IN BUILDINGS; EXTREMELY BOTHERED BY STARBURSTS, HAD SAFETY CONCERNS WITH DRIVING; EXTREMELY BOTHERED BY MULTIPLE OR DOUBLE VISION, TOTALLY DISABLING WHEN IT OCCURS; VERY BOTHERED BY GLARE, DRIVING; MODERATELY BOTHERED BY POOR LOW LIGHT VISION, NUISANCE. PREOPERATIVE VISUAL ACUITY: BEST CORRECTED DISTANCE VISUAL ACUITY (BCVA), RIGHT EYE (OD) 20/20; LEFT EYE (OS) 20/20 THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) ¿ OD 20/25; OS 20/25. MONOCULAR BCDVA ¿ OD 20/15; OS 20/15. ON OCULAR EXAM POSTERIOR CAPSULE OPACIFICATION (PCO)- BOTH EYES, WAS NOTED. THE SUBJECT IS SCHEDULED TO HAVE A YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY FOR THE POSTERIOR CAPSULE OPACIFICATION (PCO- LASER TREATMENT) IN 1 WEEK FOR THE OD AND 3 WEEKS FOR THE OS. IT WAS LEARNT THAT THE SUBJECT HAD YAG OF OD ON (B)(6) 2020. THEN ON (B)(6) 2020 ANOTHER YAG FOR THE OS. THE PATIENT VISUAL ACUITY IS UNKNOWN AT THIS TIME. NO OTHER INTERVENTION IS PLANNED. NO FURTHER INFORMATION AVAILABLE. THIS MDR REPORT PERTAINS TO

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9881582 ↗
• InjuryOct 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT300 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2018. ZXT300 IOL WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINTS OF HYPEROPIA. VISUAL ACUITY (VA) PRE-OPERATIVE 20/40 -2 AND POST-OPERATIVE 20/50. VISUAL ACUITY SYMPTOMS WERE REPORTED AS BLURRY/FUZZY. THE ZXT300 18.0 DIOPTER LENS WAS REPLACED WITH A ZXT300 18.5 DIOPTER LENS. IT WAS REPORTED THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9183269 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INSERTION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT LEFT EYE, THE DOCTOR ORDERED A CHANGE TO A DIFFERENT IMPLANT MODEL. AN INCISION ENLARGEMENT WAS PERFORMED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8831320 ↗
• InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 18.0 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THE PATIENT EXPERIENCING NIGHT TIME HALOS FOR SEVERAL MONTHS. THE REPLACEMENT LENS IS A ZCT300 18.5 DIOPTER MONOFOCAL LENS. NO COMPLICATIONS OF ANY KIND WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8713327 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. REPORTEDLY, THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO BLURRED VISION AND DYSPHOTOPSIA. THE INCISION WAS ENLARGED DURING THE REMOVAL OF THE LENS BUT NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. A ZCT300 18.0 DIOPTER LENS WAS IMPLANTED AS A REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE BEST CORRECTED VISUAL ACUITY (BCVA) BEFORE THE LENS EXCHANGE WAS 20/25. THE ACCOUNT ALSO INDICATED THAT THE EXPLANTED LENS WAS DISCARDED AT THE SURGERY CENTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8498859 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTEDLY DID NOT LIKE THE AMOUNT OF GLARE, BUT VISION WAS GOOD AFTER THE IMPLANTATION OF LENS MODEL, ZXT300 MULTIFOCAL IOL (INTRAOCULAR LENS) IN HIS RIGHT EYE (OD). AS A RESULT, LENS WAS EXPLANTED AND REPLACED WITH LENS MODEL Z9002. THROUGH FOLLOW-UP, PATIENT'S SYMPTOMS WERE FIRST NOTICED FROM ONE MONTH POST-OP. PATIENT HAD ALSO A CORRECTION, PRE-EXISTING LASIK PRIOR TO CATARACT SURGERY. NO ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED AND THE PATIENT WAS REPORTEDLY NORMAL AT THE TIME OF DISCHARGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8385119 ↗
• InjuryApr 25, 2018Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 18.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINED OF INTOLERABLE, OVERWHELMING, AND DEBILITATING GLARE, INCLUDING HALOS, CONCENTRIC CIRCLES, AND STARBURSTS. PATIENT WAS ASKED ABOUT THE ONSET DATE OF THE SYMPTOMS, SHE DID NOT REMEMBER WHEN IT STARTED, MAYBE A COUPLE WEEKS LATER, POST IMPLANT. REPORTEDLY, THE LENS IS PLANNED TO BE EXPLANTED AND EXCHANGED ON (B)(6) 2018, NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7463166 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO A RESIDUAL REFRACTIVE ERROR. THE LENS WAS EXPLANTED WITH NO COMPLICATION, NO INJURY AND NO ADDITIONAL PROCEDURES. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A HIGHER DIOPTER. PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6681372 ↗