CT LUCIA CT LUCIA 602.US/+13.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843045100805), received between Oct 14, 2022 and Feb 3, 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.

• InjuryFeb 3, 2026Use of Device Problem

  THE SURGEON STATED THAT THE LENS WAS MALROTATED IN THE EYE AND HAD TO BE CUT OUT AND COULDN'T BE SAVED. THE PATIENT HAD TO HAVE ANOTHER SURGERY TO REMOVE THE MALROTATED LENS AND REPLACE IT WITH ACIOL.

  Patient problems: Visual Impairment

  MAUDE report 24254910 ↗
• InjuryFeb 3, 2026Use of Device Problem

  THE SURGEON STATED THAT THE LENS WAS MALROTATED IN THE EYE AND HAD TO BE CUT OUT AND COULDN'T BE SAVED. HE THEN IMPLANTED A BACKUP LENS ((B)(6)).

  Patient problems: Visual Impairment

  MAUDE report 24254908 ↗
• InjuryNov 3, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE DOCTOR ATTEMPTED TO IMPLANT CT LUCIA 602 +13.5D. IT WAS REPORTED THAT THE LENS WAS DEFECTIVE AS BOTH HAPTICS BROKE. THIS IOL WAS EXPLANTED AND REPLACED WITH A BACKUP ZEISS LENS DURING THE SAME DAY WITHOUT COMPLICATION.

  Patient problems: Visual Impairment

  MAUDE report 18070104 ↗
• InjuryMay 16, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LENS WAS PLACED IN THE EYE THEN REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16943082 ↗
• InjuryMay 16, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED (NO OTHER INFORMATION WAS PROVIDED). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16942993 ↗
• InjuryOct 14, 2022Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT THE DOCTOR WAS USING THE YAMANE SCLERAL FIXATION TECHNIQUE TO IMPLANT A CT LUCIA 602, THE CASE WENT WITHOUT ANY ISSUE. HOWEVER, ON POST-OP, THE OPTIC HAD TILTED AND ROTATED 90 DEGREES. THE LENS WAS REMOVED, AND ANOTHER LENS WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15610913 ↗

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