CT LUCIA CT LUCIA 621P.AM DPT 20.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843045102281), received between Jul 17, 2024 and Jun 30, 2026 — 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.

• InjuryJun 30, 2026Use of Device Problem

  THE CUSTOMER REPORTED THAT DURING SURGERY THE HAPTIC OF THE CT LUCIA 621P LENS WOULD NOT INJECT PROPERLY AND THE LENS WAS PARTIALLY IMPLANTED IN THE CAPSULAR BAG. THE LENS WAS SUBSEQUENTLY EXPLANTED AND A SPARE ZEISS LENS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 25670072 ↗
• InjuryJul 17, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT IOL OPERATION USING A CT LUCIA 621P ON (B)(6) 2024. THE HOSPITAL PREDICTED A POST-SURGERY RESULT CLOSE TO 0, BUT THE ACTUAL RESULT WAS AROUND -1.5 MYOPIA, NECESSITATING A LENS POWER EXCHANGE. THE LENS REPLACEMENT WAS CARRIED OUT ON (B)(6) 2024.

  Patient problems: Visual Impairment

  MAUDE report 19766988 ↗

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