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

Model Number	003500-0050-673
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is being sent back.Thus, a proper device analysis could not be completed, nor the reported issues confirmed.It was mentioned by the customer that there was no damage noted during preparation for use indicating a product quality issue did not contribute to the reported issues.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: · loading strategy · lens placement technique · accessory device support · poor handling during folding and inserting 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 the haptic twisted within the optic.The doctor mentioned that he was able to fix the lens, but he decided to replace the lens.No injuries were reported.No additional information provided.
Additional Manufacturer Narrative
Field d9: updated to "yes" field g3: updated "date received by manufacturer" field g6: updated to "follow-up # 1" and "30-day" field h2: selected "correction, and device evaluation" field h3: updated to "yes".Checked "evaluation summary attached" box field h6: added component code to "4720".Added type of investigation to "10".Added investigation conclusion to "61".Field h10: added description of changes.

• 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: 17704318
• Report Number: 3010126268-2022-00060
• Device Sequence Number: 20519715
• Product Code: HQL
• UDI-Device Identifier: 00843045100942
• UDI-Public: (01)00843045100942(17)260331(27)3S2104450121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Expiration Date: 03/31/2026
• Device Model Number: 003500-0050-673
• Device Catalogue Number: 003500-0050-673
• Device Lot Number: 3S210445
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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