CT LUCIA CT LUCIA 602.US/+17.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00843045100881), received between Mar 9, 2022 and Sep 1, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (18 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Off-Label Use; Use of Device Problem

  The customer reported that the haptic of the lens kinked and therefore had to be removed from the eye. The Yamane technique was used during implantation.

  Patient problems: Visual Impairment

  MAUDE report 50534369 ↗
• InjuryJun 18, 2026Off-Label Use; Use of Device Problem

  THE CUSTOMER REPORTED THAT A CT LUCIA LENS WAS IMPLANTED USING THE YAMANE TECHNIQUE. THE LENS WAS EXPLANTED DUE TO ONE HAPTIC "TEARING AT THE JUNCTURE". ANOTHER LENS WAS IMPLANTED WITH NO ISSUES. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 25553488 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SURGERY THE PATIENT DEVELOPED ENDOPHTHALMITIS. THE SURGERY WAS PERFORMED ON (B)(6) 2025 - PARS PLANA VITRECTOMY AND INSERTION OF INTRAOCULAR LENS. ON (B)(6) 2025, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS AND HAD A VITREOUS TAP AND INJECTION OF VANCOMYCIN AND CEFTAZIDIME. CULTURES SO FAR SHOW NO GROWTH. THE PATIENT HAD A FOLLOW UP VISIT ON (B)(6) 2025 AND SHOWED IMPROVEMENT IN SYMPTOMS AND ON EXAM. THERE ARE PLANS FOR CONTINUED CLOSE FOLLOW UPS.

  Patient problems: Endophthalmitis

  MAUDE report 23632099 ↗
• InjuryAug 21, 2025Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE WEEK POST OPERATION, THE CT LUCIA 602 IOL (INTRAOCULAR LENS) HAD ROTATED AND AFFECTED THE PATIENT'S VISION. THE PATIENT ELECTED TO RETURN AND DO AN IOL EXCHANGE FOR ANOTHER LENS. THE IOL WAS EXPLANTED ON (B)(6) 2025. THE SURGICAL TECHNIQUE USED WAS NOT REPORTED. THE Z28 CARTRIDGE WAS UTILIZED (INJECTOR UNSPECIFIED), WITH NO NOTED LENS DAMAGE OR PATIENT COMPLICATIONS.

  Patient problems: Visual Impairment

  MAUDE report 22864334 ↗
• InjuryJun 30, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  DURING AN IOL IMPLANTATION, THE CT LUCIA 602 LENS WAS COMPLETELY INSERTED INTO THE EYE, AND THEN REMOVED DUE TO A BROKEN HAPTIC. THE PROCEDURE WAS PERFORMED USING THE YAMANE TECHNIQUE. A BACKUP LENS WAS IMPLANTED WITHIN THE SAME SURGERY WITH NO CLINICAL CONSEQUENCES.

  Patient problems: Visual Impairment

  MAUDE report 22362237 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED, "ONE OF OUR RETINA SURGEONS WAS TRYING TO IMPLANT A CT LUCIA 602 17.5 DIOPTER LENS. THE PATIENT BECAME UNCOOPERATIVE MID PROCEDURE, AND THE SURGEON HAD TO ABORT THE IMPLANTATION OF THE LENS. AT THAT POINT THE LENS WAS IN THE PATIENT'S EYE, IT WAS CUT INTO SEVERAL PIECES AND REMOVED, AND THE PATIENT WAS LEFT APHAKIC. THE LENS WAS DISCARDED."

  Patient problems: Visual Impairment

  MAUDE report 20779201 ↗
• InjurySep 27, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED THAT HAPTICS WERE DAMAGED AS A RESULT OF IMPROPER LOADING INTO THE CARTRIDGE BY A SCRUB TECHNICIAN. THERE WAS NO PATIENT HARM. THE LENS WAS PARTIALLY INSERTED INTO THE SULCUS USING THE YAMANE TECHNIQUE. THE LENS WAS REMOVED AND REPLACED WITH A SPARE LENS. THE LENS WAS DISCARDED.

  Patient problems: Visual Impairment

  MAUDE report 20326165 ↗
• InjuryJun 21, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT HAPTIC BENT CAUSING DISLOCATION IN EYE AFTER IMPLANTATION OF A CT LUCIA LENS. THE LENS WAS REMOVED AND REPLACED BY BACK-UP LENS DURING THE SAME SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 19588551 ↗
• InjuryFeb 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE TRYING TO LOAD A CT LUCIA LENS INTO THE PATIENTS EYE, THE LENS WOULD NOT LOAD, THEREFORE, THE LENS WAS RETRACTED. THERE ARE PLANS TO DO THE SURGERY AGAIN AS THE PATIENT WAS LEFT APHAKIC. THE DATE HAS NOT BEEN SET YET.

  Patient problems: Visual Impairment

  MAUDE report 18628551 ↗
• InjuryNov 21, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED THAT A CT LUCIA 602 LENS (SN (B)(6) ) HAD A DEFECTIVE HAPTIC AND WOULD NOT GO IN PLACE. THE LENS WAS EXPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 18185942 ↗
• InjuryOct 30, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC WAS PULLING OUT OF THE OPTIC AFTER INSERTION, THEREFORE, THE LENS WAS EXPLANTED. IT IS NOT KNOWN WHETHER ANOTHER LENS WAS IMPLANTED OR PATIENT WAS LEFT APHAKIC. IT WAS ALSO REPORTED THAT THE YAMANE TECHNIQUE WAS USED WHEN DOING THE IMPLANTATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18035569 ↗
• InjuryOct 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE CUSTOMER REPORTED THAT AN ISSUE OCCURRED WITH THE HAPTICS OF A CT LUCIA 602 LENS THAT NEEDED IT TO BE EXPLANTED AND REPLACED WITH A BACKUP LENS.

  Patient problems: Visual Impairment

  MAUDE report 17891547 ↗
• InjuryJul 20, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DEFECTIVE GLUE ON THE HAPTIC OF AN IMPLANTED LENS WAS FOUND. DECREASED VISION WAS REPORTED. IT IS PLANNED TO EXPLANT THE LENS.

  Patient problems: Visual Impairment

  MAUDE report 17367338 ↗
• InjuryMay 2, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED A ROTISSERIE TILT CASE. THE LENS WAS REMOVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16856910 ↗
• InjuryMar 15, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT IOL WAS WELL PLACED WITHOUT TILT INTRA-OP. THE PATIENT HAD A RETINAL DETACHMENT ON POD27 AND UNDERWENT REPAIR ON (B)(6) 22. ON (B)(6) 2022 HE WAS NOTED TO HAVE A TILTED IOL. ON (B)(6) 23 HE DEVELOPED A RECURRENT RETINAL DETACHMENT AND UNDERWENT COMPLEX RETINAL DETACHMENT REPAIR AND IOL REMOVAL. THE TILTED (WITH "ROTISSERIE"/TWISTED HAPTICS) IOL CAUSED IRIDODIALYSIS UPON REMOVAL AND ADDED COMPLEXITY AND MORBIDITY TO THE CASE. THE PATIENT WAS LEFT APHAKIC UNDER SILICONE OIL AND THE PROGNOSIS IS GUARDED.

  Patient problems: Visual Impairment

  MAUDE report 16547834 ↗
• InjuryMar 15, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE FIRST CT LUCIA WAS PLACED INTO THE EYE AND HAD TILT INTRAOPERATIVELY. THE LENS WAS REMOVED AND A SECOND IOL WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16547571 ↗
• InjuryMar 7, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS TILTED 90 DEGREES.LENS WAS REMOVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16495864 ↗
• InjuryMar 2, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

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

  Patient problems: Visual Impairment

  MAUDE report 16468672 ↗
• InjuryJan 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A CT LUCIA 602 LENS, THE LENS WAS EXPLANTED, HE THOUGHT THAT SOMETHING LOOKED FUNNY ABOUT THE HAPTICS AFTER THE IOL WAS INJECTED INTO THE ANTERIOR CHAMBER. HE ATTRIBUTED THIS TO THE TECHNICIAN WHO LOADED THE LENS NOT HAVING DONE SO FOR A WHILE. A JOHNSON AND JOHNSON EMERALD INJECTOR WITH THE UNFOLDER EMERALD XL DELIVERY SYSTEM WAS USED. ANOTHER CT LUCIA 602 LENS WAS IMPLANTED WITH NO ISSUES. NO PATIENT INJURY REPORTED OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16118698 ↗
• InjuryOct 28, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A DOCTOR PERFORMED A SCLERAL FIXATED IOL WITHOUT ANY ISSUES. HOWEVER, ON POST OP DAY 1. THE IOL HAD TURNED 90 DEGREES. THE IOL WAS REMOVED, AND A NEW LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15693460 ↗
• InjuryJul 22, 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 CASE WENT WITHOUT ANY ISSUE. HOWEVER, ON POST-OP DAY ONE, THE OPTIC HAD ROTATED 90 DEGREES AND WAS LYING HORIZONTALLY IN THE PUPIL. THE DOCTOR HAD TO TAKE THE PATIENT BACK TO OPERATING ROOM TO EXPLANT THE IOL. THE DOCTOR NOTED THE ISSUE WAS AT THE OPTIC/ HAPTIC JUNCTION. A SPARE LENS WAS IMPLANTED NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 15085636 ↗
• InjuryMar 9, 2022Adverse 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 THE LENS HAD SCRATCHES AND DEPOSITS ON IT. THE LENS HAD TO BE REMOVED AND COMPETITOR LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13710687 ↗

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