CT LUCIA CT LUCIA 602.US/+7.0DRecalls & reported problems
Carl Zeiss Meditec Production, LLC · 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +7.0D · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843045100676), received between Jan 9, 2025 and Jan 9, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
- Use of Device Problem1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem
CUSTOMER REPORTED, "ON (B)(6) 2024, ONE OF OUR SURGEONS HAD TO REMOVE A CT LUCIA IOL AFTER IMPLANTATION. THE SURGEON WAS PERFORMING A YAMANE PROCEDURE AND THE IOL HAPTIC WOULD NOT STAY IN PLACE IN THE SCLERAL TUNNEL, AND IT HAD TO BE REMOVED." THERE WERE NO PATIENT INJURIES REPORTED.
Patient problems: Visual Impairment
MAUDE report 21115081 ↗
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 · TerminatedIntraocular 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 · TerminatedIntraocular 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 · TerminatedPrecision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device is indicated for primary implantation in the capsular
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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