TECNIS IOL ZLB00 (REF ZLB00U0280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474560833), received between Mar 23, 2017 and Dec 29, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Torn Material” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT THAT WAS IMPLANTED WITH A ZLB00 (28.0 DIOPTER) INTRAOCULAR LENS (IOL) ENDED UP 20/70 UNCORRECTED FOR DISTANCE. THE PATIENT¿S REFRACTIVE ERROR IS MINIMAL (+0.50 -1.00 X095) WHICH GETS HIM TO 20/40 WITH DIFFICULTY. THAT THE PATIENT¿S SPHERICAL EQUIVALENT IS PLANO WHICH DOES NOT EXPLAIN THE 20/70 VISION AND NEITHER DOES THE MACULA. THE PATIENT¿S PRE-OP BCVA (BEST CORRECTED VISUAL ACUITY) WAS 20/40. THE DOCTOR REPORTED THAT THE PATIENT HAD VERY MILD IRITIS AND ALTHOUGH THE CORNEA WAS FINE AND CLEAR, THE PATIENT WAS 20/70 UNCORRECTED AND WAS NOT SEEING WELL AT THE 1-MONTH VISIT. SHE STATED THAT THE PATIENT HAS IMPROVED WHEN WAS SEEN AGAIN ABOUT 2 WEEKS AGO, THAT THE PATIENT HAD SOME EYE IRRITATION/POST-OP INFLAMMATION, BUT THE VISION HAS IMPROVED TO 20/40. IT WAS INDICATED THAT THE PATIENT HAS THE SAME LENS IN THE OTHER EYE THAT WAS PUT IN BY ANOTHER SURGEON SOME TIME AGO. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS, MEDICAL OR SURGICAL INTERVENTION OR INJURY DURING THE IMPLANT, THAT IRIS HOOKS WERE USED TO ACHIEVE DILATION WITHOUT COMPLICATION. NO LOSS OF 2 OR MORE LINES OF BEST CORRECTED VISUAL ACUITY (BCVA) WAS REPORTED AND IT WAS CONFIRMED THAT THE PAT

  Patient problems: Iritis; Irritation; Visual Impairment

  MAUDE report 8205243 ↗
• MalfunctionJan 30, 2018Torn Material; Torn Material

  IT WAS REPORTED THAT THE LENS WAS TORN/CRACKED DURING INSERTION INTO THE EYE. THERE WAS PATIENT CONTACT BUT NO INJURY. THE IOL WAS REMOVED AND REPLACED WITHOUT INCISION ENLARGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229928 ↗
• InjuryMar 23, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZLB00 28.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO MECHANICAL FAILURE. THE NATURE OF THE MECHANICAL FAILURE WAS NOT PROVIDED. THE LENS WAS CUT IN HALF AND REMOVED. INCISION WAS ENLARGED TO 4MM. HOWEVER THERE WAS NO VITRECTOMY OR PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6429987 ↗