CT LUCIA CT LUCIA 602.US/+24.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843045101024), received between Oct 14, 2022 and Feb 10, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Off-Label Use” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE IOL ROTATED AFTER BEING WELL CENTERED AND IN GOOD POSITION. LENS WAS EXPLANTED AND ANOTHER LENS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 16358937 ↗
• InjuryFeb 10, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE IOL ROTATED AFTER BEING WELL CENTERED AND IN GOOD POSITION. LENS WAS EXPLANTED AND ANOTHER LENS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 16358897 ↗
• InjuryFeb 10, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE IOL ROTATED AFTER BEING WELL CENTERED AND IN GOOD POSITION. LENS WAS EXPLANTED AND ANOTHER LENS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 16358869 ↗
• InjuryNov 10, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CASE WAS A LENS EXCHANGE WITH YAMANE INTRASCLERAL HAPTIC FIXATION. EVERYTHING SEEMED ROUTINE DURING THE CASE AND THE LENS LOOKED FINE AT THE END (CASE WAS COMBINED WITH RETINA SURGEON DUE TO THE SEVERITY OF DISLOCATION OF THE LENS THEY WERE REPLACING). THE LENS LOOKED GREAT AT THE END OF THE CASE AND LOOKED OK DAY 1 POST-OP. WHEN THE RETINA DOC SAW HER A WEEK LATER IT WAS STATED THE IOL TILTED. A WEEK LATER AT POST OP THE IOL TILTED ALMOST 90 DEGREES. THE LENS WAS EXPLANTED (B)(6) 2022, AND ANOTHER LENS IMPLANTED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 15776658 ↗
• InjuryOct 14, 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 HAPTIC WAS BROKE. THUS, THE LENS WAS REMOVED, AND A SECOND LENS WAS ATTEMPTED TO BE IMPLANTED. HOWEVER, THE IOL CONTINUED TO TILT UPWARD PREVENTING GOOD CENTRATION AND PROPER PLACEMENT. THUS, THIS LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS REPORTED NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15611322 ↗

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