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	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device cannot be returned.Thus, a proper device analysis could not be completed, nor the reported issue confirmed.It was stated by the customer that there was no damage noted to the device during preparation for use.Based on the information provided, the risk assessment for the lucia product, and based on our experience we have determined that the following factors may have cause or contributed to the damaged haptic is but is not limited to: lens placement technique, loading strategy, accessory device support, poor handling during folding and inserting.Risk assessment has been reviewed within the technical file for the three-piece hydrophobic lenses.Risk assessment identifies the implantation of an unstable iol to be caused by insufficient resistance against the compression force in the capsular bag.This is seen as normal as that may result in an additional surgery because of impaired vision.This is considered as a serious risk.The likelihood of occurrence is estimated to be occasional.This risk is deemed as 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.
Event or Problem Description
It was reported that on (b)(6) 2023 the lens had to be removed/was not implanted due to an "unstable capsular bag." the lens was explanted without harm to the patient.The patient was left aphakic until (b)(6) 2023.

• 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: 17671319
• Report Number: 3010126268-2023-00094
• Device Sequence Number: 6207798
• Product Code: HQL
• UDI-Device Identifier: 00843045100898
• UDI-Public: (01)00843045100898(17)280331
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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: 003500-0050-668
• Device Lot Number: 3S230402
• 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: 08/16/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2023
• 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