CT LUCIA CT LUCIA 602.US/+22.5DRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00843045100980), received between Sep 25, 2020 and Mar 3, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Off-Label Use; Use of Device Problem

  THE CT LUCIA 602 LENS WAS IMPLANTED USING THE YAMANE TECHNIQUE. THE LENS HAD TILTED IN THE EYE AND WAS EXPLANTED ON THE SAME DAY. THE PATIENT WAS LEFT APHAKIC AND DISCHARGED WITH NO COMPLICATIONS. THE SURGEON HAS SCHEDULED A RE-IMPLANTATION SURGERY IN APPROXIMATELY 2-3 MONTHS.

  Patient problems: Visual Impairment

  MAUDE report 24500980 ↗
• InjuryJul 21, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT AN CT LUCIA 602 LENS (IOL) WITH A KINKED HAPTIC WAS EXPLANTED. THE CUSTOMER CONFIRMED NO DAMAGE WAS NOTED DURING DEVICE PREPARATION, AND THE PROCEDURE UTILIZED A ZEISS INJECTOR WITH A Z28 CARTRIDGE. A SECOND ZEISS LENS WAS IMPLANTED TO COMPLETE THE SURGERY, THOUGH THE EXACT PLACEMENT (SULCUS OR CAPSULAR BAG) IS UNKNOWN. THE CASE WAS PROLONGED BY APPROXIMATELY 15 MINUTES DUE TO THE REMOVAL OF THE DAMAGED LENS. THE YAMANE TECHNIQUE WAS EMPLOYED DURING THE PROCEDURE, AND NO PATIENT INJURY OCCURRED.

  Patient problems: Visual Impairment

  MAUDE report 22555271 ↗
• InjuryApr 28, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  DURING IMPLANTATION ON (B)(6) 2025, THE LENS WAS OBSERVED TO HAVE TILTED. THE YAMANE TECHNIQUE WAS USED. THE LENS WAS EXPLANTED ON THE SAME DAY AND DISCARDED. A DIFFERENT LENS WAS USED FOR SCLERAL FIXATION WITHOUT FAILURE.

  Patient problems: Visual Impairment

  MAUDE report 21923225 ↗
• InjuryApr 2, 2024Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  LENS NOTED BY CUSTOMER TO BE SCRATCHED AT COMPLETION OF PROCEDURE. LENS TORE IN HALF AND FELL TO BACK OF EYE WHEN ATTEMPTING TO EXPLANT THE LENS. PATIENT WAS LEFT APHAKIC.

  Patient problems: Visual Impairment

  MAUDE report 19021816 ↗
• InjuryNov 3, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A LENS WITH A BENT HAPTIC CAUSED THE LENS TO FLIP. THIS IOL WAS EXPLANTED DURING THE SAME SURGERY; HOWEVER, IT IS UNKNOWN WHETHER ANOTHER LENS WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE OR IF THE PATIENT WAS LEFT APHAKIC.

  Patient problems: Visual Impairment

  MAUDE report 18069893 ↗
• InjuryOct 24, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT "THE HAPTIC BROKE WHILE POSITIONING THE LENS. THERE WAS PATIENT CONTACT. THE LENS WAS DISCARDED."

  Patient problems: Visual Impairment

  MAUDE report 17999445 ↗
• InjuryJul 10, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE HAPTIC WAS DAMAGED. THE LENS WAS EXPLANTED, A SECOND LENS WAS USED TO COMPLETE THE PROCEDURE DURING ANOTHER SURGERY.

  Patient problems: Visual Impairment

  MAUDE report 17289666 ↗
• InjuryJun 6, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A CT LUCIA 602 LENS NEEDED TO BE REMOVED AFTER PARTIAL INSERTION DUE TO A DAMAGED HAPTIC. ANOTHER LENS WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17076149 ↗
• InjuryJun 6, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AFTER A CT LUCIA 602 WAS IMPLANTED IN A PATIENT, THE DOCTOR WAS STATING THAT THE HAPTIC WAS MALFUNCTIONING, REMOVED THE LENS FROM THE PATIENT AND IMPLANTED THE BACKUP LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17070333 ↗
• InjuryApr 25, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT: THE ANATOMY WAS NOT SECURE. THE LENS WAS IMPLANTED AND EXPLANTED. A DIFFERENT TYPE OF LENS WAS USED TO COMPLETE THE PROCEDURE. CARTRIDGE TYPE USED FOR PLACEMENT: "B". THE CUSTOMER USED YAMANE TECHNIQUE. ADDITIONALLY, NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 16809225 ↗
• InjuryJan 24, 2023Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  THE HAPTICS ON THE LENS WAS STUCK. THE 2ND LENS WAS IMPLANTED DURING THE SAME SURGERY. THERE WERE NO ADVERSE EVENTS, AND NO SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16235480 ↗
• InjurySep 25, 2020Off-Label Use; Material Integrity Problem; Device Handling Problem; Off-Label Use; Material Integrity Problem; Device Handling Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A CT LUCIA 602 LENS IT WAS NOTED THAT THE LENS WAS BROKEN. THUS, THE LENS WAS REMOVED AND A SPARE LENS WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10587643 ↗

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