CT LUCIA CT LUCIA 602.US/+22.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00843045100973), received between Aug 18, 2022 and Feb 17, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Use of Device Problem

  IT WAS REPORTED THAT THE CT LUCIA 602 INTRAOCULAR LENS (IOL) WAS IMPLANTED AS THE PRIMARY CHOICE IN THE CILIARY SULCUS ON (B)(6) 2023. THE LENS WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2025 DUE TO SUBLUXATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW LENS (AO60 22.0) WAS PLACED IMMEDIATELY AFTER EXPLANTATION. THE SURGICAL TECHNIQUE (E.G., YAMANE TECHNIQUE) AND THE CARTRIDGE/INJECTION SYSTEM USED ARE UNKNOWN.

  Patient problems: Visual Impairment

  MAUDE report 24369734 ↗
• InjuryJan 10, 2025Use of Device Problem; Use of Device Problem

  THE HAPTIC OF A CT LUCIA 602 LENS BROKE AFTER INSERTION. IT WAS EXPLANTED AND REMOVED IN THE SAME PROCEDURE WITH ANOTHER CT LUCIA 602 LENS. NO PATIENT HARM WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 21129547 ↗
• InjuryNov 1, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS WAS TORN IN THE CARTRIDGE AND WAS NOTICED DURING THE LENS IMPLANTATION. THE LENS WAS SUCCESSFULLY REMOVED AND REPLACED WITHOUT COMPLICATION. YAMANE TECHNIQUE WAS USED TO FIXATE THE IOL.

  Patient problems: Visual Impairment

  MAUDE report 20592384 ↗
• InjuryApr 30, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED THAT THE CT LUCIA 602 HAD TILTED AFTER IMPLANTATION. THIS WAS FOLLOWED BY INCREASE IN INTRAOCULAR PRESSURE THAT NEEDED TUBE SHUNT FROM THE GLAUCOMA SURGEON. THE PATIENT HAD HISTORY OF GLAUCOMA. SUBSEQUENTLY, THE LENS WAS EXPLANTED AND ANOTHER IENS WAS IMPLANTED. YAMANE TECHNIQUE WAS USED.

  Patient problems: Intraocular Pressure Increased; Visual Impairment

  MAUDE report 19214966 ↗
• InjuryNov 20, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED THAT ON (B)(6) 2023, A CT LUCIA 602 LENS SN (B)(6) WAS IMPLANTED AND HAD ROTATED IN THE EYE. THE LENS WAS REMOVED AND ANOTHER BACKUP LENS WAS IMMEDIATELY USED TO SUCCESSFULLY REPLACE IT.

  Patient problems: Visual Impairment

  MAUDE report 18177790 ↗
• InjuryMay 17, 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 THE IOL SEVERELY TILTED. IT IS PLANNED TO EITHER REDOCK THE IOL VIA YAMANE TECHNIQUE, OR TO EXPLANT THE IOL. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16950822 ↗
• InjuryApr 25, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC TWISTED. IT IS PLANNED TO EXPLANT THE IOL ON (B)(6) 2023. NO DAMAGE NOTED TO THE DEVICE DURING PREPARATION FOR USE, AND THE SURGEON USED YAMANE TECHNIQUE. IN ADDITION, NO ADVERSE PATIENT EFFECTS, OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 16809024 ↗
• InjuryJan 31, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS WAS TWISTING POSTOPERATIVELY. THE LENS WAS REMOVED ANOTHER LENS WAS IMPLANTED. NO ADVERSE PATIENT SEQUELA REPORTED OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16274968 ↗
• InjuryAug 18, 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, THE OPTIC HAD TILTED. THE DOCTOR HAD TO TAKE THE PATIENT BACK TO OR TO EXPLANT IOL. NEW IOL WAS IMPLANTED SUCCESSFULLY WITHOUT ANY ISSUES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15251133 ↗

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