CT LUCIA CT LUCIA 602.US/+19.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00843045100928), received between Jan 9, 2023 and Feb 17, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2025. ON DAY 1, THE LENS LOOKED FINE. A WEEK LATER THE HAPTIC WAS FOUND TO BE WEAK AND THE IOL HAD ROTATED UNEXPECTEDLY. AFTER ORIGINAL IMPLANT, PATIENT NOTICED FOREIGN BODY SENSATION, PAIN, REDNESS, AND TEARING. THE YAMANE TECHNIQUE WAS USED DURING IMPLANTATION. THE IOL WAS EXPLANTED (B)(6) 2025 AND REPLACED. PATIENT IS DOING FINE NOW.

  Patient problems: Visual Impairment

  MAUDE report 24369026 ↗
• InjurySep 12, 2025Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CT LUCIA 602 IOL WAS EXPLANTED DUE TO THE PATIENT'S ANATOMY AND REPLACED WITH A BACKUP LENS, WHICH WILL NOT BE RETURNED. THE PROCEDURE WAS COMPLETED USING THE YAMANE TECHNIQUE WITHOUT REPORTED PATIENT INJURY, SURGICAL DELAY, OR USE OF ANOTHER ZEISS LENS.

  Patient problems: Visual Impairment

  MAUDE report 23038190 ↗
• InjuryMay 20, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR NOTED A LINEAR SCRATCH ON THE CT LUCIA 602 LENS POST IMPLANTATION CAUSED BY THE ZEISS R28 INJECTOR. THERE WAS NO DAMAGE OBSERVED TO THE LENS PRIOR TO FOLDING/LOADING INTO THE INJECTION CARTRIDGE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER CT LUCIA 602 LENS.

  Patient problems: Visual Impairment

  MAUDE report 22055100 ↗
• InjuryApr 18, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC CAME OFF. THE LENS WAS IMPLANTED AND THEN EXPLANTED AFTER THE HAPTIC BROKE. THERE WAS PATIENT CONTACT, BUT NO HARM REPORTED. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. THE SURGEON USED THE YAMANE TECHNIQUE TO IMPLANT INTO SCLERA.

  Patient problems: Visual Impairment

  MAUDE report 21867258 ↗
• InjuryNov 14, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS ROTATED IN THE EYE. THE ROTATIONAL ISSUE WAS NOTED ON POD1. THE DOCTOR EXPLANTED THE LENS FOR AN ACIOL (EXPLANTED LENS WAS DISCARDED). HE REMOVED THE LENS AND REPLACED WITH A DIFFERENT LENS AT A DIFFERENT DATE.

  Patient problems: Visual Impairment

  MAUDE report 20686012 ↗
• InjuryNov 12, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  HAPTIC BROKE IN PATIENT'S EYE. YAMANE TECHNIQUE WAS UTILIZED. LENS WAS EXPLANTED AND REPLACED WITH NEW ZEISS LENS IN THE SAME SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 20668935 ↗
• InjuryNov 4, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  LENS WAS IMPLANTED INTO THE PATIENT'S EYE USING THE YAMANE TECHNIQUE, BUT IT "STARTED TO COME OUT." LENS WAS EXPLANTED AND REPLACED WITH ANOTHER ZEISS LENS IN THE SAME SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 20605291 ↗
• InjuryJul 23, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE IOL TWISTED IN THE EYE. IT WAS EXPLANTED AND REPLACED DURING THE SAME PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 19811822 ↗
• InjuryJul 3, 2024Use of Device Problem; Use of Device Problem

  HAPTIC BROKE OFF WHILE THE DOCTOR WAS TRYING TO MANEUVER THE LENS IN THE EYE. LENS WAS EXPLANTED IN THE SAME SURGERY AND REPLACED.

  Patient problems: Visual Impairment

  MAUDE report 19672198 ↗
• InjuryMay 3, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC BROKE UPON INSERTION. THE LENS WAS EXPLANTED AND ANOTHER CT LUCIA 602 LENS WAS IMPLANTED DURING THE SAME PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 19242610 ↗
• InjuryJan 30, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC OF A CT LUCIA 602 WAS KINKED. THE B CARTRIDGE WAS USED WITH VISCOAT FOR IMPLANTATION. AS THE LENS WAS FULLY INSERTED, THE LENS HAD TO BE REMOVED AND WAS DISCARDED. THERE WAS NO PATIENT HARM REPORTED. A BACKUP ZEISS LENS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 18611267 ↗
• InjuryNov 20, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE LENS WAS EXPLANTED AND REPLACED DURING THE SAME SURGERY. THE RETURNED DEVICE DISPLAYED DAMAGED HAPTICS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18169766 ↗
• InjuryNov 6, 2023Off-Label Use; Off-Label Use

  ON (B)(6) 2023 THE CUSTOMER IMPLANTED A CT LUCIA 602 LENS USING THE YAMANE TECHNIQUE. THE LENS WAS REMOVED AND REPLACED SHORTLY AFTER INITIAL IMPLANTATION.

  Patient problems: Visual Impairment

  MAUDE report 18080219 ↗
• InjuryOct 31, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER IMPLANTED THE CT LUCIA 602 LENS ON (B)(6) 2023. IT WAS REPORTED THAT THE SUPERIOR HAPTIC WAS NOT FULLY EMBEDDED. THERE WAS A GAP FROM THE END OF THE HAPTIC TO WHERE IT SHOULD BE EMBEDDED WITHIN THE OPTIC. DUE TO AN IMPROPERLY STAKED HAPTIC, THE IOL WAS ABLE TO ROTATE. IT TOOK MULTIPLE ATTEMPTS TO REPOSITION THE IOL, AND ADDED NEARLY AN HOUR TO THE PROCEDURE. THIS IOL WAS EXPLANTED ON (B)(6) 2023, AND A BACKUP ZEISS LENS WAS IMPLANTED THE SAME DAY WITHOUT COMPLICATION.

  Patient problems: Visual Impairment

  MAUDE report 18043851 ↗
• InjuryMay 16, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LENS WAS UNSTABLE, THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16943048 ↗
• 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. THE LENS IS PLANNED TO BE EXPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16258545 ↗
• InjuryJan 9, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER THE DOCTOR IMPLANTED A CT LUCIA 602 USING THE YAMANE TECHNIQUE ON POD5 THE IOL WAS EXPERIENCING A "ROTISSERIE" TILT. THE LENS WAS REMOVED, AND A COMPETITOR LENS WAS IMPLANTED. IT WAS STATED THAT THE TECH "MANHANDLED" ONE OF THE HAPTICS WHEN LOADING THE LENS AND IT WAS A BIT OF A CHALLENGE TO GET IT INTO THE LUMEN OF THE TSK NEEDLE. NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED.

  Patient problems: Retinal Detachment; Visual Impairment

  MAUDE report 16127892 ↗

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