CT LUCIA CT LUCIA 602.US/+15.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843045100843), received between May 16, 2023 and Jul 13, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT THE CT LUCIA 602 LENS COULD NOT BE UTILIZED AS INTENDED, AS EXPLANTATION WAS REQUIRED FOLLOWING IMPLANTATION. THE CT LUCIA 602 LENS WAS INADVERTENTLY IMPLANTED IN A REVERSED ORIENTATION BY THE SURGEON. A BACKUP CT LUCIA 602 LENS WAS SUBSEQUENTLY IMPLANTED, ENABLING THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. NO NEGATIVE PATIENT IMPACT WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 25796636 ↗
• InjuryMay 29, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A DOCTOR IMPLANTED THE CT LUCIA 602 LENS AND THEN REMOVE IT. THE PATIENT WAS LEFT APHAKIC. THE PATIENT IS COMING BACK FOR A DIFFERENT LENS. THE DOCTOR SAID THE ISSUE OCCURRED DUE TO THE PATIENT'S ANATOMY. THE LENS TILTED AFTER IMPLANTATION. NO PATIENT HARM WAS REPORTED. A MONARCH CARTRIDGE B WAS USED WITH MONARCH FORCEPS. THE PROCEDURE WAS PERFORMED ON THE LEFT EYE OF A MALE PATIENT. THE YAMANE TECHNIQUE WAS USED FOR THIS PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 22107390 ↗
• InjuryApr 25, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC WAS BROKEN AFTER INSERTION. THE LENS HAD TO BE EXPLANTED AND REPLACED BY A BACK-UP LENS. THE YAMANE TECHNIQUE WAS USED.

  Patient problems: Visual Impairment

  MAUDE report 19188412 ↗
• InjuryNov 20, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT DURING AN IMPLANTATION USING THE YAMANE TECHNIQUE ON (B)(6) 2023, THE HAPTIC CAME LOOSE FROM THE OPTIC LENS. THE LENS WAS EXPLANTED ON (B)(6) 2023. ANOTHER LENS WAS NOT USED TO REPLACE THE EXPLANTED LENS, THE PATIENT WAS LEFT APHAKIC.

  Patient problems: Visual Impairment

  MAUDE report 18170279 ↗
• InjuryOct 17, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CUSTOMER REPORTED "UPON IMPLANTATION THERE WAS A PROBLEM WITH THE HAPTIC AT WHICH POINT THE LENS WAS EXPLANTED AND A BACKUP WAS USED SUCCESSFULLY."

  Patient problems: Visual Impairment

  MAUDE report 17952067 ↗
• InjuryMay 16, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC BROKE. LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16943022 ↗

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