CT LUCIA CT LUCIA 602.US/+23.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843045100997), received between Jun 20, 2023 and Jul 27, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 27, 2026Device Handling Problem

  The customer reported that the lens CT Lucia 602 was implanted and subsequently explanted. No patient injury was reported. No additional information provided..

  Patient problems: Visual Impairment

  MAUDE report 50038831 ↗
• InjuryNov 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING SURGERY THE HAPTIC ON THE CT LUCIA 602 DIDN'T GO ALL THE WAY INTO THE EYE AND WAS CATCHING ON THE IRIS. THE SURGEON CUT IT OUT AND USED A BACKUP CT LUCIA 602 LENS. THIS WAS NOT A HAPTIC ROTATION AND SIMPLY AN ERROR DURING INJECTION. NO NEGATIVE PATIENT IMPACT WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 23594400 ↗
• InjuryJul 3, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC WAS NOT ATTACHED TO THE OPTIC CORRECTLY AND THIS MADE THE LENS TORQUE IN THE EYE. LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN THE SAME SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 19672301 ↗
• InjuryApr 30, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC BROKE AFTER IT WAS IMPLANTED. THE LENS WAS EXPLANTED AND ANOTHER CT LUCIA 602 LENS WAS IMPLANTED DURING THE SAME PROCEDURE. YAMANE TECHNIQUE WAS USED.

  Patient problems: Visual Impairment

  MAUDE report 19216153 ↗
• InjuryJun 20, 2023Optical Decentration; Off-Label Use; Use of Device Problem; Optical Decentration; Off-Label Use; Use of Device Problem

  (B)(6) IMPLANTED A CT LUCIA ON (B)(6) 2023. ON THE DAY OF IMPLANTATION, THE OPTIC APPEARED UNDAMAGED, THE HAPTICS LOOKED FINE, AND PROPERLY POSITIONED. DURING FIRST POST OPERATIVE DAY, IT WAS FOUND THAT THE HAPTIC HAD SLIPPED OUT OF THE OPTIC. PATIENT'S VISUAL ACUITY AND SATISFACTION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17167973 ↗
• InjuryJun 20, 2023Optical Decentration; Off-Label Use; Use of Device Problem; Optical Decentration; Off-Label Use; Use of Device Problem

  DR. (B)(6) IMPLANTED THE LENS FINE ON (B)(6) 2023. POST OP DAY 1, (B)(6) 2023, THE LENS LOOKED FINE AND CENTERED. THE PATIENT RETURNED DAY THREE, (B)(6) 2023, AND THE LENS HAD DECENTERED. AT THE TIME, THE DOCTOR ASSUMED THE HAPTIC HAD SLIPPED OUT OF THE SCLERA. ON (B)(6) 2023, THE DOCTOR DECIDED TO EXPLANT THE LENS AND REPLACE IT WITH ANOTHER LENS. THE DOCTOR FOUND THE HAPTIC STILL POSITIONED PROPERLY IN THE SCLERA. THE PROBLEM WAS THAT THE HAPTIC HAD SLIPPED OUT OF THE OPTIC ON ONE SIDE.

  Patient problems: Visual Impairment

  MAUDE report 17167970 ↗

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