CT LUCIA CT LUCIA 602.US/+14.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843045100829), received between Jan 11, 2023 and May 21, 2026 — 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.

• InjuryMay 21, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT THE CT LUCIA 602 IOL (INTRAOCULAR LENS) WAS EXPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 25246288 ↗
• InjuryMar 3, 2026Off-Label Use; Use of Device Problem

  THE CT LUCIA 602, SN: (B)(6), WAS IMPLANTED IN THE ANTERIOR CHAMBER ON (B)(6) 2025 USING THE YAMANE TECHNIQUE. ON (B)(6) 2026, THE LENS APPEARED TO BE DISLOCATED AND WAS EXPLANTED. A NEW CTLUCIA 602 LENS WAS SUCCESSFULLY IMPLANTED. THERE WERE NO INJURIES TO THE PATIENT.

  Patient problems: Visual Impairment

  MAUDE report 24500714 ↗
• InjuryNov 5, 2024Use of Device Problem; Use of Device Problem

  THE SURGEON REPORTED THAT THE IOL FOLDED INCORRECTLY DURING ADVANCEMENT THROUGH THE INJECTOR CREATING A CREASE. THE LENS WAS EXPLANTED AND REPLACED DURING THE SAME SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 20613216 ↗
• InjuryJan 31, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 IOL TILTED SIGNIFICANTLY WITHIN THE FIRST MONTH OF THE POST-OPERATIVE PERIOD. THE YAMANE TECHNIQUE, WHICH IS CONSIDERED OFF-LABEL USAGE, WAS USED FOR SUTURING.

  Patient problems: Visual Impairment

  MAUDE report 18616853 ↗
• InjuryMay 1, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR HAD A CASE WHERE THE LENS WAS POSITIONED WELL AT THE END OF THE CASE, BUT THE NEXT DAY IT HAD ROTATED A FULL 180 DEGREES. THERE ARE PLANS TO EXPLANT THE LENS.

  Patient problems: Visual Impairment

  MAUDE report 16850311 ↗
• InjuryJan 11, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AFTER THE DOCTOR IMPLANTED A CT LUCIA 602 THE IOL TILTED 90 DEGREES. THE SURGEON BELIEVES THE ISSUE COULD HAVE BEEN CAUSED BY LARGE WHITE TO WHITE CORNEAL DIAMETER. THE LENS WAS REMOVED, AND A COMPETITOR LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 16141457 ↗

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