TECNIS IOL ZXT300 (REF ZXT300U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474606319), received between Jul 11, 2017 and Oct 26, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTERIOR CHAMBER BROKE AND THE SURGEON HAD TO USE A DIFFERENT INTRAOCULAR LENS (IOL). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12701485 ↗
• InjuryMar 5, 2021Adverse 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 DUE TO BLURRY VISION AND REFRACTIVE SURPRISE. LENS WAS EXPLANTED AND A DIFFERENT MODEL IOL BUT SAME DIOPTER POWER (16.5 D) WAS IMPLANTED WITHOUT COMPLICATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11423050 ↗
• InjuryApr 15, 2019Adverse 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 PATIENTS LEFT EYE BECAUSE THE PATIENT WAS DISSATISFIED WITH THE RESULTS. THE INCISION WAS ENLARGED TO EXPLANT THE LENS. THE LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION IOL. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8516791 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 16.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED BECAUSE OF RESIDUAL ASTIGMATISM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7649119 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY ON (B)(6) 2017, AT THE PATIENT''S FOLLOW UP VISIT WITH THE DOCTOR, THE PATIENT'S MANIFEST REFRACTION SHOWED THE PATIENT''S SPHERE WAS -1.00. ALSO, THE PATIENT''S REFRACTION ON (B)(6) 2017, WAS -0.25 X -0.50 X 40 AT 20/20. REPORTEDLY, THE PATIENT DID HAVE DRY EYE AT ONE OF HER VISITS AND THE DOCTOR DISCONTINUED THE PATIENT''S NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) AND PRESCRIBED ARTIFICIAL TEARS. THE PATIENT IS DUE BACK FOR A REFRACTION REPEAT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7184804 ↗
• InjuryJul 11, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED ON MONDAY, (B)(6) 2017. ON (B)(6) 2017, RECEIVED INFORMATION THAT THE LENS WAS GOING TO BE EXPLANTED ON MONDAY, (B)(6) 2017, AS APPARENTLY THE WRONG DIOPTER POWER LENS WAS IMPLANTED. NO PATIENT HARM WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6704612 ↗