TECNIS IOL ZXT150 (REF ZXT150U090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604988), received between May 25, 2017 and Aug 25, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) (B)(6) 2020. PATIENT REPORTS THAT SHE NEVER HAD CLEAR VISION AFTER HER SURGERY, AND STATED HER VISION IS BLURRED UP TO 27 INCHES IN FRONT OF HER. SHE WAS ASSURED SHE WOULD HAVE MID-RANGE VISION AND SHE DOES NOT. SHE HAS NOT BEEN ABLE TO READ LABELS, SEE HER PHONE, LEMON SEEDS, ETC. SINCE DAY OF SURGERY. DISTANCE VISION IS PRETTY GOOD, BUT SHE STILL CAN¿T SEE SIGNS AT NIGHT WHEN SHE IS DRIVING OR ANYTHING CLOSE-UP. STREET SIGNS ARE VISIBLE IF SHE SITS AND FOCUSES ON THEM AT STOP SIGNS, BUT NOT IN THE APPROACHING DISTANCE OR WHIRRING BY. SHE HAS TRIED 3 PAIRS OF GLASSES IN ORDER TO SEE WITH THE FOLLOWING RESULTS: POWER OF 3.25 ALLOWS HER TO SEE AT PRECISELY 10 INCHES. BUT NOT CLOSER OR FARTHER. POWER OF 2.0 ALLOWS HER TO SEE ~2 FEET WITH NO MIDRANGE. SIGNS WITH SMALLER PRINT THAN SPEED LIMITS ARE BLURRY. CANNOT SEE THE SIGNS, LET ALONE WORDS ON THEM AT NIGHT. POWER 1.5 ALLOWS HER TO DRIVE, BUT SHE CAN¿T READ HER PHONE WITH IT. SHE HAS TRIED DIFFERENT CONTACTS AND THIS DID NOT WORK EITHER; CANNOT SEE LABELS WITH +.25 ADD HIGH CONTACT LENS. SHE HAS USED EYE DROPS BUT IT HASN¿T HELPED. PRE &

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment

  MAUDE report 10451346 ↗
• InjuryMay 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZXT150 +0.90 DIOPTERS, WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE LEFT EYE OF A MALE PATIENT BECAUSE OF UNEXPECTED MYOPIC OUTCOME. ANOTHER LENS, SAME MODEL SMALLER DIOPTER (+0.80) WAS IMPLANTED AS REPLACEMENT. NO INCISION ENLARGEMENT, NO SUTURE USED AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6593192 ↗