TECNIS IOL ZXT150 (REF ZXT150U140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474605084), received between Dec 20, 2016 and Nov 25, 2020 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 6 MONTH VISIT A PATIENT WHO HAD BILATERAL IMPLANTS BECAME MODERATELY BOTHERED BY HALOS- DRIVING; MODERATELY BOTHERED BY STARBURSTS- UNCOMFORTABLE DRIVING; MODERATELY BOTHERED BY MULTIPLE OR DOUBLE VISION- WATCHING TV; MODERATELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT- JUDGEMENT IN DRIVING; EXTREMELY BOTHERED BY POOR LOW LIGHT VISION- INSIDE THE HOME. ALTHOUGH, THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) - RIGHT EYE (OD) 20/25; LEFT EYE (OS) 20/40. MONOCULAR ARE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) ¿ OD 20/20; OS 20/20 AND NO INTERVENTION PLANNED. NO OTHER INFORMATION WAS PROVIDED. 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; Visual Disturbances

  MAUDE report 10902347 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 6 MONTH VISIT A PATIENT WHO HAD BILATERAL IMPLANTS BECAME MODERATELY BOTHERED BY HALOS- DRIVING; MODERATELY BOTHERED BY STARBURSTS- UNCOMFORTABLE DRIVING; MODERATELY BOTHERED BY MULTIPLE OR DOUBLE VISION- WATCHING TV; MODERATELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT- JUDGEMENT IN DRIVING; EXTREMELY BOTHERED BY POOR LOW LIGHT VISION- INSIDE THE HOME. ALTHOUGH, THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) - RIGHT EYE (OD) 20/25; LEFT EYE (OS) 20/40. MONOCULAR ARE BEST CORRECTED VISUAL ACUITY (BCDVA) ¿ OD 20/20; OS 20/20 AND NO INTERVENTION PLANNED. 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: Halo; No Code Available; Visual Disturbances

  MAUDE report 10902115 ↗
• MalfunctionNov 13, 2019Unintended Movement; Unintended Movement

  IN A CLINICAL STUDY POST-OP EVALUATION, THE SITE NOTED AN AXIS MISALIGNMENT OF THE INTRAOCULAR LENS (IOL), MODEL ZXT150 14.0 DIOPTER. THE LENS HAD A ROTATION OF 15 DEGREES. ON (B)(6) 2019, IOL AXIS PLACEMENT OF THE RIGHT EYE (OD) WAS 135 DEGREES. ON (B)(6) 2019, IOL AXIS (OD) WAS 150 DEGREES. THERE IS NO SECONDARY SURGICAL INTERVENTION IS PLANNED AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EMDR REPORT IS FOR THE PATIENT'S RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S LEFT EYE (OS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9313794 ↗
• InjuryAug 13, 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 WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE PATIENT WAS UNHAPPY WITH GLARES AND HALOS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7779689 ↗
• InjuryOct 25, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A CALCULATION ERROR/POWER MISSED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 11.5. POST-OPERATIVELY, THE PATIENT'S VISION IS 20/20 AND THERE WERE NO REPORTED COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6975441 ↗
• InjuryMay 8, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A ZXT150 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE IOL WAS NOT CENTERED CORRECTLY IN THE INITIAL IMPLANT. THE PHYSICIAN REPLACED THE LENS WITH A ZCB00 IOL AND THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6553082 ↗
• InjuryApr 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 14.0 DIOPTER WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO RESIDUAL REFRACTIVE ERROR. THE LENS WAS EXPLANTED WITH NO COMPLICATIONS, NO INJURY AND NO ADDITIONAL PROCEDURES. THE LENS WAS REPLACED WITH A MODEL ZXT225 OF THE SAME DIOPTER SIZE. PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6524853 ↗
• MalfunctionDec 20, 2016Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A TORIC INTRAOCULAR LENS (IOL) IT WAS VERY DIFFICULT AND TIGHT TO ADVANCE THE LENS IN THE CARTRIDGE. THE SURGEON WAS ABLE TO DELIVER THE LENS INTO THE PATIENT'S EYE WITH A LOT OF FORCE AND USING A SECOND INSTRUMENT. THE SURGEON NOTICED THAT THE TIP OF THE PLUNGER NICKED THE EDGE OF THE IOL BUT BELIEVES THE PATIENT WILL BE OK AND THE VISION WILL NOT BE COMPROMISED. THERE IS NOT PLAN ON EXCHANGING THE LENS. NO FURTHER INFORMATION WAS PROVIDED. TWO MDRS WILL BE FILED. ONE FOR THE CARTRIDGE AND ONE FOR THE LENS (THIS REPORT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6188117 ↗