TECNIS IOL ZCT300 (REF ZCT300U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474553255), received between Apr 13, 2017 and Apr 6, 2020 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2020Adverse 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 A SURPRISE OUTCOME. REPLACEMENT IOL WAS A ZXT300, 18.5 DIOPTER POWER. THERE WAS NO COMPLICATIONS OR PATIENT HARM. EXPLANTED IOL NOT SAVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9927465 ↗
• InjuryDec 7, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT HAD A ZCT300 INTRAOCULAR LENS (IOL) IMPLANTED IN THE RIGHT EYE ON (B)(6) 2017 AND THE IOL AXIS WAS 87 DEGREES. ON (B)(6) 2017, THE IOL AXIS WAS 125 DEGREES. THERE WAS A 38-DEGREE ROTATION WHICH REQUIRED REPOSITIONING ON (B)(6) 2017. THE REPOSITIONING PROCEDURE HAD A POSITIVE OUTCOME. THERE WERE NO VISUAL COMPLAINTS OR OTHER MEDICAL FINDINGS AT THE 1-MONTH POST-SURGERY VISIT. AT THE 1 MONTH POST OP VISIT: UNCORRECTED VISUAL ACUITY 20/60, MRX-0.75+1.75X0.45, BEST CORRECTED VISUAL ACUITY 20/40. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 7097957 ↗
• InjuryNov 14, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT300 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, WITHOUT INCIDENT BECAUSE THE DOCTOR STATED THAT HE CHOSE THE WRONG CYLINDER POWER FOR THE PATIENT. THE LENS WAS REPLACED WITH A ZCT150 16.5 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7031618 ↗
• InjuryOct 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO SIGNIFICANT RESIDUAL ASTIGMATISM. AT EXPLANT, THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A ZCT225 16.5 DIOPTER IOL. REPORTEDLY, THERE WAS NO COMPLICATION AND NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6950559 ↗
• InjuryApr 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A ZCT300 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6488936 ↗