CT LUCIA CT LUCIA 602.US/+21.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00843045100966), received between Oct 11, 2021 and Mar 6, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (17 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Use of Device Problem

  IT WAS REPORTED THAT AFTER SURGERY CONCLUDED, THE DOCTOR NOTICED A BENT HAPTIC ON THE CT LUCIA 602. THE YAMANE TECHNIQUE WAS EMPLOYED DURING THE SURGERY. A SECOND CT LUCIA 602 LENS WAS IMPLANTED TWO WEEKS LATER. THE PATIENT'S CONDITION WAS GOOD AT THE ONE-WEEK POST-OPERATIVE VISIT. DURING THE PREPARATION FOR USE, NO DAMAGE WAS NOTED TO THE DEVICE.

  Patient problems: Visual Impairment

  MAUDE report 24535919 ↗
• InjuryAug 19, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  DURING A CT LUCIA 602 LENS IMPLANTATION PROCEDURE, THE HAPTIC BECAME KINKED. THE DEVICE WAS EXPLANTED AND A BACKUP CT LUCIA 602 LENS WAS IMPLANTED WITHIN THE SAME SURGERY. THE PROCEDURE WAS PERFORMED USING A ZEISS CARTRIDGE AND INJECTOR SYSTEM. THE YAMANE TECHNIQUE WAS USED DURING THE PROCEDURE. THE AFFECTED DEVICE IS NOT RETURNABLE. NO DAMAGE WAS NOTED DURING PREPARATION OR PRIOR TO LOADING THE LENS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 22841831 ↗
• InjuryOct 16, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS WAS "SPINNING" IN THE EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME SURGERY.

  Patient problems: Swelling/ Edema; Visual Impairment

  MAUDE report 20464724 ↗
• InjuryMar 7, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE HAPTICS WERE NOT STABLE AFTER PLACING IOL INTO THE EYE USING THE YAMANE TECHNIQUE. THE LENS HAD TO BE EXPLANTED AND REPLACED BY A DIFFERENT LENS. THE INCISION WAS ENLARGED IN ORDER TO EXPLANT THE LENS.

  Patient problems: Visual Impairment

  MAUDE report 18862354 ↗
• InjuryMar 7, 2024Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT A DEFECT IN THE OPTICAL HAPTIC WAS DISCOVERED AFTER IMPLANTATION. THE LENS HAD TO BE EXPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18855878 ↗
• 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 18477754 ↗
• InjurySep 28, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT "A ZEISS CT LUCIA 602 WAS IMPLANTED VIA A HAPTIC FIXATED TECHNIQUE (YAMANE TECHNIQUE). AT THE END OF THE CASE, THE LENS WAS WELL CENTERED AND PLANAR WITHIN THE PUPILLARY AND VISUAL AXIS. THE NEXT MORNING ON POSTOP DAY 1, THERE WAS A DEMONSTRATING 90 DEGREE ROTATION OF THE IOL ALONG THE VERTICAL AXIS." LENS WAS EXPLANTED AND REPLACED WITH ANOTHER IOL.

  Patient problems: Visual Impairment

  MAUDE report 17836702 ↗
• InjuryJun 6, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 LENS WAS PARTIALLY IMPLANTED WHEN THE HAPTIC TWISTED. THE DOCTOR WAS ABLE TO REMOVE THE LENS WITHOUT PATIENT INJURY. NO ADVERSE EVENTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 17076070 ↗
• InjuryMay 17, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC JUNCTION BROKE, RESULTING IN THE IOL TILTING, THE IOL WAS REMOVED AND ANOTHER LENS WAS IMPLANTED. NO ADVERSE EFFECTS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 16950749 ↗
• InjuryMay 16, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE LENS FLIPPED (TWISTED). THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 16942945 ↗
• InjuryMay 1, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR HAD A CASE WHERE THE LENS WAS POSITIONED WELL AT THE END OF THE CASE, BUT THE NEXT DAY IT HAD ROTATED A FULL 180 DEGREES. THE LENS HAS BEEN EXPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 16850333 ↗
• InjuryMar 2, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE IOL HAPTIC WAS DISTORTED OR TWISTED WITHIN THE HAPTIC JUNCTION AFTER INITIAL SUCCESSFUL SCLERAL FIXATION, CAUSING SIGNIFICANT LENS TILT. THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16470500 ↗
• InjuryFeb 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER IMPLANTING A CT LUCIA 602 THE IOL TILTED.

  Patient problems: Visual Impairment

  MAUDE report 16309422 ↗
• InjuryJan 23, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER IMPLANTING A CT LUCIA 602 LENS THE IOL TILTED POD1. LENS WAS EXPLANTED ANOTHER LENS WAS IMPLANTED. PATIENT WAS NOT INJURED, NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16230719 ↗
• InjuryJan 9, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER TRYING TO MANIPULATE THE TRAILING HAPTIC FOR THE YAMANE TECHNIQUE THE HAPTIC DISINSERTED FROM THE OPTIC WHEN GRASPED WITH THE INTRAOCULAR FORCEPS. THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16128048 ↗
• InjuryFeb 2, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AFTER A CT LUCIA 602 WAS IMPLANTED IT WAS NOTICED THERE WAS A KINK IN THE HAPTIC. THUS, THE LENS WAS REMOVED AND A BACKUP LENS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 13423813 ↗
• InjuryDec 3, 2021Off-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 602 WAS IMPLANTED USING THE SCLERAL FIXATION TECHNIQUE. THE PATIENT COULDN'T TOLERATE THE PAIN CAUSED BY THE SCLERAL FIXATION TECHNIQUE; THUS, THE DOCTOR DECIDED TO REMOVE THE LENS AND IMPLANT AN ANTERIOR CHAMBER LENS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Eye Pain

  MAUDE report 12926799 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A CT LUCIA 602 LENS WAS INSERTED INTO A PATIENT'S EYE IT WAS NOTED THAT THE HAPTIC WAS BROKEN. THE IOL WAS REMOVED FROM THE EYE SUCCESSFULLY WITHOUT PATIENT INJURY. SPARE LENS WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12606192 ↗

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