MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA 602

Model Number	602
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "the lens had vaulted and turned sideways the next day after the lens was implanted.The lens was explanted on (b)(6)2023 during that time the surgeons noticed that a haptic was broken at the haptic lens junction.The lens was removed, and the patient is apakic.Next steps are for the surgeon to wait a period of time and try and implant another lens.It was stated that the doctor used the yamane technique and standard injector.No patient injuries were confirmed.".
Additional Manufacturer Narrative
The device is not being sent back thus a proper device analysis could not be completed nor the reported issue confirmed.Based on the information provided, the risk assessment for the lucia product and based on our experience and other complaints that have already been resolved we have determined that the following factor may have cause or contributed to the damaged haptic is but is not limited to: misplacement of the lens.This which may occur during ovd application, the cannula may catch the edge of the lens or haptic; thus, removing the lens off the "track" which is inside the cartridge.This may also cause the lens to fold improperly.The lens should fold in a "u" shape and if it does not this will cause the lens to not eject correctly and could even cause the lens to get damaged.At this time, without a proper device analysis, a definitive root cause cannot be determined however, there is no indication of a product quality issue with respect to manufacturing, design, or labeling of the lens.Risk assessment has been reviewed within the technical file for hydrophobic lens.Risk assessment identifies failed injection or damaged haptic to possibly be caused by poor handling during folding and inserting which may result in delay in surgery, use of replacement lens.This is controlled by the physician skill/training.This is considered as a reasonably foreseeable misuse which may result in extended surgery because of damage to the lens/injector and replacement is required.This is considered as a minor severity of damage that may cause temporary injury or disability which requires no additional surgical intervention.The likelihood of occurrence is estimated to be occasional the resulting risk is deemed acceptable.The device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lens that would have caused or contributed to the nature of this complaint.Additionally, our lenses are 100% inspected before they leave our manufacturing site.Therefore, we are confident that the lens was processed per standard operating procedures and inspections and met all criteria for release.

• Brand Name: CT LUCIA 602
• Common Device Name: CT LUCIA 602
• Manufacturer (Section D): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s vintage ave. bld. a; ontario CA 91761
• Manufacturer (Section G): CARL ZEISS MEDITEC PRODUCTION LLC; 1040 s vintage ave. bld. a; ontario CA 91761
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 16710313
• Report Number: 3010126268-2023-00049
• Device Sequence Number: 7346661
• Product Code: HQL
• UDI-Device Identifier: 00843045100904
• UDI-Public: (01)00843045100904(17)261031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-669
• Device Lot Number: 3S211193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown