CT LUCIA CT LUCIA 602.US/+19.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00843045100911), received between Oct 4, 2021 and May 21, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT THE CT LUCIA 602 IOL (INTRAOCULAR LENS) WAS EXPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25244380 ↗
• InjuryDec 3, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC OF A CT LUCIA 602 LENS WAS FOUND TO BE BROKEN DURING IMPLANTATION. YAMANE TECHNIQUE WAS USED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 23710475 ↗
• InjuryMay 22, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS NO DAMAGE OBSERVED TO THE CT LUCIA 602 LENS EITHER AT THE TIME OF FOLDING/LOADING OR POST INSERTION. HOWEVER WHILE THE LENS WAS OBSERVED TO BE WELL CENTERED AND FREE FROM ANY SCRATCHES, THE HAPTICS COULD NOT BE ANCHORED INTO THE SULCUS AS ADDITIONAL LOSS OF INTEGRITY TO THE POSTERIOR CAPSULE HAD OCCURRED WITH VITREOUS PROLAPSE. THE LENS WAS SECTIONED AND REMOVED WITH THE MACKOOL LENS CUTTER AND FORCEPS AND AN ANTERIOR VITRECTOMY PERFORMED. PATIENT RECOVERED UNEVENTFULLY IN AN APHAKIC STATE AND WILL BE REFERRED FOR IMPLANTATION OF A SUTURED LENS ONCE HEALING IS COMPLETE.

  Patient problems: Visual Impairment

  MAUDE report 22073369 ↗
• InjuryApr 28, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  DURING IMPLANTATION ON (B)(6) 2025, THE LENS WAS OBSERVED TO HAVE TILTED. THE YAMANE TECHNIQUE WAS USED. THE LENS WAS EXPLANTED ON THE SAME DAY AND DISCARDED. A DIFFERENT LENS WAS USED FOR SCLERAL FIXATION WITHOUT FAILURE.

  Patient problems: Visual Impairment

  MAUDE report 21923237 ↗
• InjuryFeb 18, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  A CT LUCIA 602 WAS IMPLANTED ON (B)(6) 2025 USING THE YAMANE TECHNIQUE FOR SCLERAL FIXATION, AND THE PATIENT LATER REPORTED THE LENS HAD TILTED. THE PATIENT WAS SCHEDULED FOR REPOSITIONING ON (B)(6) 2025, WITH NO EXPLANTATION OR INJURY REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 21404002 ↗
• InjuryMar 26, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS HAD A KINKED BACK HAPTIC. THE LENS HAD TO BE EXPLANTED AND REPLACED BY A DIFFERENT LENS. YAMANE TECHNIQUE WAS USED.

  Patient problems: Visual Impairment

  MAUDE report 18983330 ↗
• 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 18855727 ↗
• InjuryJan 26, 2024Off-Label Use; Use of Device Problem; Device Damaged by Another Device; Off-Label Use; Use of Device Problem; Device Damaged by Another Device

  IT WAS REPORTED THAT AS THE DOCTOR WAS INSERTING THE CT LUCIA 602 LENS INTO THE EYE, HE NOTICED THERE WAS A SCRATCH ON THE LENS. HE PROCEEDED TO RETRACT THE LENS AND USED A ZEISS BACK UP LENS TO COMPLETE THE SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 18592335 ↗
• InjuryMay 19, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE BACK OF THE HAPTIC LENS GOT CAUGHT ON THE METAL INJECTOR AND RIPPED OFF. THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED.

  Patient problems: Visual Impairment

  MAUDE report 16961424 ↗
• InjuryMar 20, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT "THE DOCTOR IS GOING TO HAVE TO REPLACE THE LUCIA LENS BECAUSE IT IS TILTED,THE LENS IS STILL IN THE PATIENT'S EYE. WHEN DR. NOTTAGE DOES THE IOL EXCHANGE SHE WANTS TO MAKE SURE IT IS NOT THE SAME LOT#" NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16577175 ↗
• InjuryMar 19, 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 THE SURGEON DIDN'T LIKE HOW THE LENS WAS SITTING IN THE EYE. THE LENS WAS REMOVED. NO PATIENT INJURY. SPARE LENS WAS USED TO SUCCESSFULLY COMPLETE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13826031 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A CT LUCIA 602 IT WAS NOTED THE IOL HAD OPACITIFICATION. AS OF NOW THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12573120 ↗

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