TECNIS IOL ZXT150 (REF ZXT150U255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474605312), received between Nov 6, 2017 and Jul 23, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A WHITE SUBSTANCE ON THE HAPTIC OF LENS. THE SURGEON IMPLANTED AND EXPLANTED THE LENS AT THE TIME IT WAS OBSERVED AND SUCCESSFULLY REPLACED THE LENS WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER). THERE WAS NO UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221128 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO WAS IMPLANTED WITH A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL) IS EXPERIENCING A LACK OF CLEAR VISION. IT WAS INDICATED THAT THE PATIENT IS A DENTAL ASSISTANT, UNABLE TO SEE TO WORK AND DRIVING IS CHALLENGING FOR THE PATIENT. IT WAS NOTED THAT THE LENS WAS SCHEDULED TO BE EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10731227 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED GLARES AND HALOS AFTER IMPLANTATION OF MODEL A ZXT150 INTRAOCULAR LENS. THE LENS WAS EXPLANTED AND REPLACED WITH NON-JOHNSON & JOHNSON PRODUCT. THE PATIENT IS HAPPY WITH THE RESULTS OF THE REPLACEMENT LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8307732 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150, 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT'S SYMPTOMS OF SEVERE HALOS, GLARE AND SEVERE VISUAL DISTURBANCES IN BOTH EYES (OU). THE SYMPTOMS WERE CAUSING SEVERE MIGRAINES IN THE PATIENT AND SHE WAS UNABLE TO ACCOMMODATE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. A ZCT225 LENS (DIOPTER UNKNOWN) WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, THE PATIENT IS DOING WELL POST EXPLANT. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/100; VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/40. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE PATIENT¿S RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8041015 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE (OS). THERE WAS A PATIENT CONTACT. PER FOLLOW-UP, PATIENT HAD CATARACT SURGERY WITH OPTIWAVE REFRACTIVE ANALYSIS (ORA) ON (B)(6) 2018 AND A SYMFONY LENS IMPLANTED. THE ORA CALLED FOR A ZXT150 22.5, SO THAT¿S WHAT WAS IMPLANTED. WHEN PATIENT CAME BACK FOR FOLLOW UPS, HE COMPLAINED OF BLURRED VISION IN THAT EYE. UPON REFRACTION, THE PATIENT WAS STILL FOUND TO HAVE 1.50 RESIDUAL CYLINDER. PATIENT'S PRE-EXISTING CONDITION¿ HYPERTENSION (HTN), HEART DISEASE, GASTROESOPHAGEAL REFLUX DISEASE (GERD), OSTEOARTHRITIS, GOUT, DIVERTICULOSIS, AND ATRIAL FIBRILLATION. PRE-OPERATION BEST VISUAL ACUITY (BVA) ¿ 20/40 -2, POST-OPERATION BVA ¿ 20/30 -2, THE PATIENT IS ONLY ONE AND HALF (1.5) WEEKS POST-OP. THE ORIGINAL IOL HAS BEEN DISCARDED BY SURGERY CENTER. THE ORIGINAL INCISION WAS REENTERED, BUT NOT ENLARGED. THERE WERE NO OTHER INJURIES SUSTAINED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7657156 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO AN UNEXPLAINED REFRACTIVE ERROR. THE REPLACEMENT LENS WAS A ZCB00 23.5. THERE WAS AN INCISION ENLARGEMENT TO REMOVE THE LENS WITH NO VITRECTOMY OR CAPSULAR TEAR. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS DOING WELL WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7005255 ↗