CT LUCIA CT LUCIA 602.US/+20.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00843045100935), received between Aug 26, 2021 and Dec 19, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (16 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER A CT LUCIA 602 LENS WAS IMPLANTED INTO THE PATIENT'S EYE, IT WAS OBSERVED THAT THE HAPTIC WAS BROKEN. THE DOCTOR EXPLANTED THE LENS AND REPLACED IT WITH ANOTHER ONE DURING THE SAME SURGERY. YAMANE TECHNIQUE WAS USED.

  Patient problems: Visual Impairment

  MAUDE report 23854099 ↗
• InjuryNov 18, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS NOTICED IN THE CT LUCIA 602 IOL (INTRAOCULAR LENS) AFTER IMPLANTATION. THEREFORE, THE IOL WAS EXPLANTED, AND A BACKUP IOL OF THE SAME POWER WAS SUCCESSFULLY IMPLANTED. THE CUSTOMER REPORTED THAT THE EXPLANTED IOL WAS NOT SAVED AND THEREFORE NOT AVAILABLE FOR RETURN.

  Patient problems: Visual Impairment

  MAUDE report 23585481 ↗
• InjuryDec 11, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  A CUSTOMER REPORTED THE CT LUCIA 602 LENS TO BE "DAMAGED AND EXPLANTED" AFTER USE OF THE YAMANE TECHNIQUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 20904918 ↗
• InjuryOct 16, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE CT LUCIA 602 LENS WAS INITIALLY IMPLANTED USING THE YAMANE TECHNIQUE. HOWEVER, THE SURGEON ENCOUNTERED DIFFICULTY CENTERING THE LENS AND ULTIMATELY HAD TO EXPLANT IT AND REPLACE IT WITH ANOTHER STYLE OF LENS. THE LENS WAS NOT DAMAGED PRIOR TO INSERTION, AND NO COMPLICATIONS OCCURRED DURING THE PROCEDURE. DISCOVISC VISCOELASTIC WAS USED. THE SURGERY PROCEEDED AS PLANNED, AND THE PATIENT IS REPORTED TO BE DOING WELL POST-OPERATIVELY.

  Patient problems: Visual Impairment

  MAUDE report 20463480 ↗
• InjurySep 12, 2024Material Deformation; Material Deformation

  CUSTOMER REPORTED THAT AFTER A CT LUCIA 602 LENS HAD BEEN IMPLANTED, THE DOCTOR NOTICED THAT IT HAD A DEFECT. AN INDENTATION OR CREASE ALONG THE LENS WAS NOTICED. THE DOCTOR PROMPTLY REMOVED THE LENS AND REPLACED WITH ANOTHER ONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 20204391 ↗
• InjurySep 2, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  DURING A CASE, THERE WAS NOTICEABLE TILT TO THE LENS, DUE TO HOW THE HAPTICS WERE MANEUVERED AFTER IMPLANTATION. THE LENS WAS EXPLANTED. AS THE SURGEON COULD NOT RESOLVE THE TILT. AND A NEW LENS WAS PLACED, DURING THE SAME PROCEDURE. THE YAMANE TECHNIQUE WAS USED.

  Patient problems: Visual Impairment

  MAUDE report 20122501 ↗
• InjuryAug 7, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT UPON THE LENS BEING LOADED, THE SCRUB TECH NOTICED THAT THE HAPTIC WAS FOLDED AND BENT. THERE WAS PATIENT CONTACT. THE CUSTOMER REPORTED VIA EMAIL THAT A BROKEN HAPTIC WAS NOTICED DURING INJECTION INTO THE SULCUS. THE LENS WAS REMOVED AND REPLACED WITH A DIFFERENT LENS.

  Patient problems: Visual Impairment

  MAUDE report 19933865 ↗
• InjuryApr 15, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC BROKE AFTER IMPLANTATION. THE LENS HAD TO BE EXPLANTED AND REPLACED BY A BACK-UP LENS.

  Patient problems: Visual Impairment

  MAUDE report 19111628 ↗
• InjuryJan 17, 2024Optical Decentration; Off-Label Use; Use of Device Problem; Optical Decentration; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 LENS COULD NOT BE CENTERED AFTER USING THE YAMANE TECHNIQUE FOR IMPLANTATION. THE LENS WAS EXPLANTED DURING THE SAME SURGERY. THE PATIENT WAS LEFT APHAKIC.

  Patient problems: Visual Impairment

  MAUDE report 18530131 ↗
• InjuryJan 17, 2024Optical Decentration; Off-Label Use; Use of Device Problem; Optical Decentration; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 LENS COULD NOT BE CENTERED AFTER USING THE YAMANE TECHNIQUE FOR IMPLANTATION. THE LENS WAS EXPLANTED DURING THE SAME SURGERY. THE PATIENT WAS LEFT APHAKIC.

  Patient problems: Visual Impairment

  MAUDE report 18530034 ↗
• InjuryOct 13, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2023 THE CUSTOMER NOTICED A SCRATCH ON THE LENS. THE CUSTOMER STATED THERE WAS A 5 MINUTE DELAY TO REPLACE THE AFFECTED LENS WITH ANOTHER ZEISS CT LUCIA LENS. THERE WAS NO DAMAGE NOTED DURING PREPARATION FOR USE AND THERE WERE NO ADVERSE EFFECTS.

  Patient problems: Visual Impairment

  MAUDE report 17936341 ↗
• InjuryMay 3, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED, "I HAVE JUST HAD MY THIRD EXPERIENCE OF A COMPLETELY TILTED YAMANE FIXATED CT LUCIA. I HAVE JUST RESTARTED USING THIS LENS AND I DID CHECK THIS ONE PRIOR TO INSERTION (DID THE SLIGHT TENSION WITH FORCEPS ON THE OPTIC HAPTIC JUNCTION). THEREFORE, DESPITE IT BEING A MUCH EASIER LENS TO USE FOR YAMANE, I WILL NOT BE USING THIS LENS AGAIN FOR THAT INDICATION UNTIL WE HAVE AN ENTIRELY NEW BATCH." UPDATE: RECEIVED FEEDBACK FROM CUSTOMER ON (B)(6) .(UCT-4). PATIENT'S VISION IS NEGATIVELY IMPACTED AND AN EXPLANTATION IS PLANNED (HAS NOT OCCURRED YET).

  Patient problems: Visual Impairment

  MAUDE report 16863705 ↗
• InjuryJan 27, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS TILTED 90 DEGREES POST OP ON DAY 1. EXPLANATION IS BEING PLANNED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16257990 ↗
• InjuryJan 24, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTICS WERE FOUND TO BE DAMAGED/NOT USEABLE UPON INSERTION. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16234247 ↗
• InjuryJan 24, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTICS WERE FOUND TO BE DAMAGED/ NOT USEABLE UPON INSERTION.

  Patient problems: Visual Impairment

  MAUDE report 16234190 ↗
• InjuryJan 13, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT DESCRIBES LOOKING THROUGH BINOCULARS WITH DARK CRESCENTS INSIDE AND INFERIOR VISION. LENS WAS REMOVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16163146 ↗
• InjuryDec 16, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 LENS WAS EXPLANTED BECAUSE THE IOL WAS FOUND TO TILT PERPENDICULAR TO THE IRIS PLANE AFTER USING THE YAMANE TECHNIQUE. ANOTHER SPARE LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15997359 ↗
• InjurySep 15, 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, THE HAPTIC FLANGE SLIPPED THROUGH THE SCLERAL TUNNEL DESPITE A NORMAL SIZE TUNNEL AND MELT OF THE HAPTIC THE LENS WAS REMOVED. A SPARE LENS WAS ATTEMPTED TO BE USED HOWEVER UPON INJECTION OF THE IOL IT WAS NOTED THAT THE LEADING HAPTIC WAS COMPLETELY DISINSERTED FROM THE OPTIC. THE LENS WAS REMOVED, AND THE PATIENT WAS LEFT APHAKIC. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15432701 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A CT LUCIA 602 IT WAS NOTED THAT THE HAPTIC WAS DAMAGED. THUS THE LENS WAS EXPLANTED AND A SPARE 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 12373881 ↗

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-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
• 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