CT LUCIA CT LUCIA 602.US/+26.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843045101055), received between Jun 3, 2022 and Nov 14, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (P100016); they may or may not involve this specific model.

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.

• InjuryNov 14, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS ROTATED IN THE EYE. THE ROTATIONAL ISSUE WAS NOTED ON POD1. THE DOCTOR EXPLANTED THE LENS FOR AN ACIOL (EXPLANTED LENS WAS DISCARDED).

  Patient problems: Visual Impairment

  MAUDE report 20686028 ↗
• InjuryNov 8, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR WAS USING THE YAMANE SCLERAL FIXATION TECHNIQUE TO IMPLANT A CT LUCIA 602, IT WAS NOTED THAT THE HAPTICS DISINSERTED FROM THE OPTIC. THUS, THE LENS WAS REMOVED, AND A SECOND LENS WAS ATTEMPTED TO BE IMPLANTED. HOWEVER, THE HAPTIC BROKE OFF WHEN IT WAS BEING PULLED OUT OF THE TROCAR. THUS, THE LENS WAS REMOVED, AND THE PATIENT WAS LEFT APHAKIC.

  Patient problems: Visual Impairment

  MAUDE report 15754631 ↗
• InjuryJun 3, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A CT LUCIA 602 LENS IT WAS NOTED THAT THE LENS WAS DAMAGED. THUS, THE LENS WAS REMOVED, AND A SPARE LENS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS REPORTED THE CUSTOMER IS USING AN EMERALD SERIES INJECTOR TO INJECT THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14594089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100016. One submission often covers many models, so check the product and lot details in each record.

• Z-1309-2015 · Feb 13, 2015 · Terminated
  Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the
• Z-1077-2012 · Aug 2, 2011 · Terminated
  Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device is indicated for primary implantation in the capsular
• Z-1076-2012 · Aug 2, 2011 · Terminated
  Intraocular Lens (IOL). Model: EC-3, Serial Number: 1169371106, 1169401106, 1169471106 The device is indicated for primary implantation in the capsular bag of the eye for the visu