CT LUCIA CT LUCIA 602.US/+17.0DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843045100874), received between Dec 13, 2022 and Oct 8, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2024Use of Device Problem; Use of Device Problem

  LENS IMPLANTED ON (B)(6) 2024 AND EXPLANTED ON (B)(6) 2024 IN A 2ND SURGERY DUE TO A "DISLOCATION". LENS WAS REPLACED IMMEDIATELY AFTER EXPLANTATION WITH NEW CT LUCIA 602 IOL.

  Patient problems: Visual Impairment

  MAUDE report 20404016 ↗
• InjuryApr 10, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT: "LENS WAS IMPLANTED, SURGEON WAS MANIPULATING LENS TO CORRECT POSITION AND NOTED THE HAPTIC HAD BROKEN OFF. LENS EXPLANTED AND WAS REPLACED WITH AN AC LENS."

  Patient problems: Visual Impairment

  MAUDE report 16708863 ↗
• InjuryDec 13, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 WAS PLACED, HOWEVER, THE HAPTIC WAS SPINNING AT THE OPTICAL JUNCTION AND COULD NOT ORIENT IN THE REVERSE S CONFIGURATION. THUS, THE LENS WAS REMOVED. A SECOND ATTEMPT WAS NOT ATTEMPTED DUE TO PATIENT HAVING EXCESSIVE EDEMA IN THE EYE FROM TRYING TO POSITION THE FIRST LENS. A MONARCH EJECTOR AND B CARTRIDGE WAS USED TO LOAD THE LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15973898 ↗

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