CT LUCIA CT LUCIA 602.US/+16.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843045100867), received between Aug 20, 2020 and May 16, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE WAS DAMAGED UPON IMPLANTATION DURING LOADING. THERE WAS PATIENT CONTACT, THE LENS WAS EXTRACTED FROM THE PATIENT. THE PATIENT WAS LEFT APHAKIC AFTER BACK UP LENS COULD NOT BE LOADED.

  Patient problems: Visual Impairment

  MAUDE report 19333054 ↗
• InjuryNov 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE CUSTOMER REPORTED THAT ON (B)(6) 2023, THE DOCTOR IMPLANTED AN IOL IN A PATIENT FROM ALABAMA. THE IOL WAS PERFECT AT THE END OF THE CASE, BUT HAD EXPERIENCED TILTING THE DAYS FOLLOWING. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER ZEISS LENS ON (B)(6) 2023.

  Patient problems: Visual Impairment

  MAUDE report 18080495 ↗
• InjuryOct 15, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR TRIED TO USE A CT LUCIA 602 THAT DID NOT FOLD CORRECTLY. THE LENS WOULD NOT STOP FROM TILTING. THUS, THE DOCTOR CUT OUT THE LENS AND USED A BACK UP LENS. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15612425 ↗
• InjuryAug 20, 2020Material Integrity Problem; Device Handling Problem; Material Integrity Problem; Device Handling Problem

  IT WAS REPORTED THAT AFTER IMPLANTING THE LENS IT WAS NOTED THAT THE LENS HAD A "RIP" IN IT. AS A RESULT THE LENS WAS REMOVED WITHIN THE SAME PROCEDURE. A NEW LENS WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431940 ↗

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