CT LUCIA CT LUCIA 602.US/+23.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843045101000), received between Apr 1, 2022 and Oct 23, 2024 — classified as 5 injuries.

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

• InjuryOct 23, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  SURGEON REPORTS THAT DURING SURGERY, THE HAPTICS OF THE CT LUCIA 602 LENS BENT. THE LENS WAS EXPLANTED ON THE SAME DAY AND A BACKUP LENS WAS SUCCESSFULLY USED.

  Patient problems: Visual Impairment

  MAUDE report 20517879 ↗
• InjuryJan 9, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CT LUCIA 602 LENS WAS REPORTED TO HAVE ROTATED AND THEN EXPLANTED. THE YAMANE TECHNIQUE AND ALCON B CARTRIDGE WAS USED FOR THE SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 18479852 ↗
• InjuryJan 27, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LENS WAS DEFECTIVE IN HAPTIC OPTIC JUNCTION. THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY WHEN REMOVING THE LENS. NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16257376 ↗
• InjuryMay 12, 2022Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A CT LUCIA WAS BEING IMPLANTED USING THE INTRASCLERAL HAPTIC FIXATION. DURING THE CASE WHILE THE SECOND HAPTIC WAS BEING EXTERNALIZED THE FIRST HAPTIC DISLODGED FROM IT'S SCLERAL FIXATED POSITION. AFTER ATTEMPTS TO FIXATE THE HAPTICS THE OPTIC OF THE IOL WAS CONTINUALLY DECENTERED. THE CT LUCIA IOL WAS REMOVED FROM THE EYE AND THERE WAS NO INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14379848 ↗
• InjuryApr 1, 2022Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method; Off-Label Use; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING THE ATTEMPT TO IMPLANT THE LENS USING THE YAMANE TECHNIQUE, THE LENS COULD NOT BE SECURED. THUS, THE LENS WAS EXPLANTED AND AN ANTERIOR CHAMBER LENS WAS USED INSTEAD. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13977699 ↗

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