CT LUCIA CT LUCIA 602.US/+26.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843045101062), received between Nov 12, 2021 and Jan 13, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AFTER IMPLANTING A CT LUCIA 602 LENS THE DOCTOR FELT THAT THE LENS WAS NOT STABLE OR SEATED CORRECTLY. THUS, THE DOCTOR DECIDED TO REMOVE THE LENS AND IMPLANT AN ANTERIOR CHAMBER LENS. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13255824 ↗
• InjuryNov 12, 2021Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A CT LUCIA 602 THE LENS TILTED. THE DOCTOR REMOVED THE LENS AND REPLACED IT WITH A BACKUP CT LUCIA 602 LENS DURING THE SAME SURGERY. IT WAS NOTED THAT THE SECOND LENS ALSO STARTED TO TILT. A SPECIAL SUTURING WAS PERFORMED IN THE ATTEMPT TO MINIMIZE THE TILT AND WAS LEFT IN THE PATIENT'S EYE. DURING POST OP IT WAS NOTED THE IOL HAD TILTED AND HAD TO BE EXPLANTED. ANOTHER LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12806820 ↗

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