CT LUCIA CT LUCIA 602.US/+20.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00843045100942), received between Aug 16, 2021 and Apr 24, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Off-Label Use; Use of Device Problem

  THE CUSTOMER REPORTED THAT A CT LUCIA 602 LENS WAS IMPLANTED USING THE YAMANE TECHNIQUE AND EXPLANTED DURING THE SAME SURGERY DUE TO LENS ROTATION. OCUCOAT WAS USED. THERE WAS NO PATIENT HARM. A BACKUP CT LUCIA 602 LENS WAS USED AND IMPLANTED. NO NEGATIVE PATIENT IMPACT WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 24986352 ↗
• InjuryDec 1, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS ROTATED 90 DEGREES ON THE WRONG AXIS DURING POST-OP. THE LENS WAS EXPLANTED AND REPLACED DURING A DIFFERENT DAY. THE DATE WHEN THE LENS WAS EXPLANTED WAS NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18252891 ↗
• InjuryOct 30, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC ROTATED, AND SO THE LENS WAS EXPLANTED. IT IS NOT KNOWN WHETHER ANOTHER LENS WAS IMPLANTED OR PATIENT WAS LEFT APHAKIC. IT WAS ALSO REPORTED THAT THE YAMANE TECHNIQUE WAS USED WHEN DOING THE IMPLANTATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 18035219 ↗
• InjurySep 7, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC TWISTED WITHIN THE OPTIC. THE DOCTOR MENTIONED THAT HE WAS ABLE TO FIX THE LENS, BUT HE DECIDED TO REPLACE THE LENS. NO INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17704318 ↗
• InjurySep 1, 2023Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023, THE DOCTOR USED A CT LUCIA 602 20.5 LENS AND WAS NOT ABLE TO THREAD IT AFTER IT WAS INJECTED INTO THE EYE. BECAUSE OF THIS, HE HAD TO CUT THE LENS OUT THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671149 ↗
• InjuryJun 15, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT, "WE HAVE AN IMPLANTED AND REMOVED IOL DUE TO ISSUES WITH THE HAPTICS. THE DOCTOR REQUESTED THEY OPEN AND USE BACK UP LENS CT LUCIA 602."

  Patient problems: Visual Impairment

  MAUDE report 17140432 ↗
• InjuryMay 30, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 LENS WAS INSERTED AND REMOVED DUE TO THE HAPTIC BEING DAMAGED. ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17027888 ↗
• InjuryApr 25, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC TWISTED. THE LENS WAS EXPLANTED. NO DAMAGE NOTED TO THE DEVICE DURING PREPARATION FOR USE, AND THE SURGEON USED YAMANE TECHNIQUE. IN ADDITION, NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 16809101 ↗
• InjuryMar 17, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AFTER IMPLANTING A CT LUCIA 602, THE IOL TILTED. LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16568411 ↗
• InjuryMar 13, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED SHORTLY AFTER BEING IMPLANTED BY DR. SHAH. THE LENS WAS EXPLANTED DUE TO THE INFERIOR HAPTIC PULLING THROUGH WHILE BEING POSITIONED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16532819 ↗
• InjuryMar 7, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE LENS TILTED 90 DEGREES.LENS WAS REMOVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16495982 ↗
• InjuryJan 13, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT DESCRIBES LOOKING THROUGH BINOCULARS WITH DARK CRESCENTS INSIDE AND INFERIOR VISION. LENS WAS REMOVED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16163345 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A CT LUCIA 602 IT WAS NOTED THAT THE LENS HAD A SCRATCH ON IT. THE LENS WAS EXPLANTED AND ANOTHER 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: Visual Impairment

  MAUDE report 12327939 ↗

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