CT LUCIA CT LUCIA 602.US/+24.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843045101017), received between Jun 3, 2022 and Jan 9, 2024 — 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.

• InjuryJan 9, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  CT LUCIA 602 LENS WAS REPORTED TO HAVE ROTATED AND THEN EXPLANTED. THE YAMANE TECHNIQUE AND ALCON B CARTRIDGE WAS USED FOR THE SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 18479845 ↗
• InjuryOct 9, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTICS OF A CT LUCIA 602 LENS DISINSERTED DURING IMPLANTATION. THE PATIENT WAS LEFT APHAKIC.

  Patient problems: Visual Impairment

  MAUDE report 17902080 ↗
• InjuryOct 9, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTICS OF A CT LUCIA 602 LENS DISINSERTED DURING IMPLANTATION. THE PATIENT WAS LEFT APHAKIC.

  Patient problems: Visual Impairment

  MAUDE report 17902075 ↗
• InjuryAug 15, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED ON (B)(6) 2023 THAT THE LENS WAS LOADED INCORRECTLY BY THE USER DURING SURGERY ON (B)(6) 2023, AND EXPLANTED THE DAME DAY. THERE WAS PATIENT CONTACT, BUT THE LENS WAS NOT USED. IT WAS REPLACED BY ANOTHER LENSE DURING THE SAME SURGERY. THE DOCTOR USED THE YAMANE TECHNIQUE. THE CUSTOMER STATED THAT THE DEVICE WILL NOT BE SENT BACK.

  Patient problems: Visual Impairment

  MAUDE report 17551436 ↗
• InjuryJun 3, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A CT LUCIA 602 LENS IT WAS NOTED THAT THE LENS WAS DAMAGED. THUS, THE LENS WAS REMOVED, AND A SPARE LENS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS REPORTED THE CUSTOMER IS USING AN EMERALD SERIES INJECTOR TO INJECT THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14594296 ↗
• InjuryJun 3, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF A CT LUCIA 602 LENS IT WAS NOTED THAT THE LENS WAS DAMAGED. THUS, THE LENS WAS REMOVED, AND A SPARE LENS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. IT WAS REPORTED THE CUSTOMER IS USING AN EMERALD SERIES INJECTOR TO INJECT THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14594192 ↗

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