CT LUCIA CT LUCIA 602.US/+18.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00843045100898), received between Oct 8, 2020 and Feb 11, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 LENS ROTATED 90 DEGREES AFTER BEING IMPLANTED USING THE YAMANE TECHNIQUE, WHICH IS AN OFF-LABEL IMPLANTATION METHOD. FURTHERMORE, THE LENS WAS IMPLANTED USING A NON-ZEISS CARTRIDGE AND INSERTER. THE ROTATION WAS SEEN AT 1 WEEK POST OPERATION. THE SURGEON PERFORMED A LASER LOCK TECHNIQUE TO REPOSITION THE LENS IN A 2ND SURGERY, AVOIDING EXPLANTATION.

  Patient problems: Visual Impairment

  MAUDE report 21360596 ↗
• InjuryJul 22, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE HAPTIC WAS DAMAGED DURING THE INSERTION PROCESS UTILIZING YAMANE TECHNIQUE. THE LENS (SN (B)(6) WAS EXPLANTED WITH NO HARM TO THE PATIENT. ANOTHER CT LUCIA LENS WAS PLACED.

  Patient problems: Visual Impairment

  MAUDE report 19801537 ↗
• InjuryApr 2, 2024Optical Decentration; Off-Label Use; Use of Device Problem; Optical Decentration; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A SUBLUXATION OF THE LENS. ORIGINAL SURGERY (IMPLANTATION) WAS ON (B)(6) 2024. THE NEXT DAY, THE PATIENT COMPLAINED OF VISUAL DISTURBANCE. LENS EXPLANTED AND REPLACED WITH ANOTHER CT LUCIA 602 WITH POWER 18.0 THE NEXT DAY (B)(6) 2024.

  Patient problems: Visual Impairment

  MAUDE report 19018695 ↗
• InjuryDec 21, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, USING THE YAMANE TECHNIQUE, ON OCTOBER 23, 2023, THE HAPTIC OF A CT LUCIA 602 BROKE WHILE SECURING. THE CORNEA STARTED TO SWELL DUE TO DIFFICULT ANATOMY AND MANIPULATION. THE PROCEDURE WENT 107 MINUTES BEYOND THE PLANNED TIME. THE LENS WAS EXPLANTED DURING THE SAME PROCEDURE AND DISCARDED. THE PATIENT WAS LEFT APHAKIC. THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING PREPARATION FOR USE. NO ISSUES POST OPERATION.

  Patient problems: Keratitis; Visual Impairment

  MAUDE report 18378798 ↗
• InjuryOct 30, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE HAPTIC DISINSERTED DURING A LENS IMPLANTATION SURGERY WITH A 20G YAMANE TECHNIQUE ON (B)(6) 2023. THE LENS WAS EXPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 18035829 ↗
• InjurySep 1, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 THE LENS HAD TO BE REMOVED/WAS NOT IMPLANTED DUE TO AN "UNSTABLE CAPSULAR BAG." THE LENS WAS EXPLANTED WITHOUT HARM TO THE PATIENT. THE PATIENT WAS LEFT APHAKIC UNTIL (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 17671319 ↗
• InjuryFeb 16, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE IOL ROTATED. THE LENS WAS EXPLANTED ON (B)(6), 2023. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16389959 ↗
• InjuryFeb 10, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC PULLED OUT OF THE OPTIC. LENS WAS EXPLANTED, AND ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16358816 ↗
• InjuryFeb 10, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC PULLED OUT OF THE OPTIC. LENS WAS EXPLANTED, AND ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16358703 ↗
• 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 LENS WAS REMOVED BECAUSE THE HAPTIC BROKE AFTER IT WAS IMPLANTED. AN ANTERIOR CHAMBER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16308384 ↗
• InjuryNov 23, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DR. (B)(6) PERFORMED A SECONDARY LENS IMPLANTATION WITH SCLERAL FIXATION AT MY FACILITY AND RAN INTO SOME DIFFICULTY. THIS PROCEDURE WAS NECESSITATED BY HER PREVIOUS CATARACT PROCEDURE REQUIRING AN ANTERIOR VITRECTOMY DUE TO SUBLUXED CAPSULE AND ZONULES. HE INSERTED A CT LUCIA IOL INTO THE EYE AND WHILE MANIPULATING IT INTO POSITION, ONE OF THE HAPTICS DETACHED FROM THE IOL. HE REMOVED THE LENS IMMEDIATELY AND REPLACED WITH ANOTHER CT LUCIA LENS. UPON SEEING THE PATIENT FOR FOLLOW-UP THE NEXT WEEK, HE DISCOVERED THAT THE SECOND LENS' HAPTIC HAD DETACHED FROM THE LENS AS WELL. THE LENS WAS ALSO REMOVED, AND ANOTHER LENS IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 15855928 ↗
• InjuryNov 23, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR REPORTED A CASE WHERE THE LENS WAS TITLED. THE LENS WAS REMOVED ON (B)(6) 2022, AND A COMPETITOR LENS WAS IMPLANTED. PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15855364 ↗
• InjuryJan 13, 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 WHEN LOADING THE LENS, THE HAPTICS WERE NOTED TO EASILY KINK TO THE POINT WHERE THE LENS HAD TO BE REMOVED FROM THE EYE. TWO ADDITIONAL LENSES WERE ATTEMPTED TO BE IMPLANTED; HOWEVER, ALSO EXPERIENCED THE SAME ISSUE AND RESULTED IN THE IOL TILTING. THUS, THE LENSES HAD TO BE REMOVED FROM THE EYE. A FOURTH LENS WAS IMPLANTED WITHIN THE SAME PROCEDURE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13255844 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INJECTING A CT LUCIA 602 THE PATIENT STARTED BLEEDING THE DOCTOR THE DECIDED TO REMOVE THE LENS. IT WAS STATED THAT THERE WAS NOTHING WRONG WITH THE LENS. NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10656164 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INJECTING A CT LUCIA 602 THE PATIENT STARTED BLEEDING THE DOCTOR THE DECIDED TO REMOVE THE LENS. IT WAS STATED THAT THERE WAS NOTHING WRONG WITH THE LENS. NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10649201 ↗

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