TECNIS IOL ZMB00 (REF ZMB00U0115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474535459), received between Jul 9, 2021 and Jul 9, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO NO NEAR OR INTERMEDIATE VISUAL ACUITY. INCISION WAS ENLARGED TO EXPLANT THE LENS FROM PATIENT'S EYE BUT NO VITRECTOMY OR SUTURES WERE REQUIRED. ADDITIONAL DETAILS RECEIVED STATES THAT THERE WAS NO ISSUE WITH THE LENS. PATIENT WAS UNABLE TO USE THE COMPUTER, SEE THE DASHBOARD OR READ A MAGAZINE WITHOUT GLASSES PRIOR TO EXPLANT. THERE IS NO KNOWN PRE-EXISTING EYE DISEASE .PATIENT HAS NOT LOST TWO (2) OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA). THE REPLACEMENT LENS USED IS OF DIFFERENT MODEL ZXR00. PATIENT IS STILL HEALING AND WAS 20/30 UNCORRECTED DISTANCE VISION (UCDV) AT ONE (1) WEEK POST-OPERATION. PATIENT/ USER OUTCOME: BEST CORRECTED DISTANCE VISION (BCDV) PRE-ANY SURGERY 20/200, UNCORRECTED DISTANCE VISION (UCDV) POST-ORIGINAL SURGERY 20/30-2. TARGET REFRACTIVE VALUE PRE-INITIAL IMPLANT -0.37. TARGET REFRACTIVE VALUE POST-INITIAL IMPLANT +0.50-0.50 X90 20/20. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 12140898 ↗