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

Model Number 602

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Visual Impairment (2138)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.Thus, a proper device analysis could not be completed nor the reported issue confirmed.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.Based on the information provided, the risk assessment for the lucia product, and our experience we have determined that the following factors may have cause or contributed to the reported issue is but is not limited to: · patient pathology.· patient pre-existing conditions.· side effects to medications.· existing damage or inflammation.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.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 Description

The customer reported that the doctor had to remove a lens with blemish on it and replaced it with a new one.There was patient contact.No additional information provided.

• Brand Name: CT LUCIA
• Type of Device: 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: 18132570
• MDR Text Key: 328067097
• Report Number: 3010126268-2023-00119
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100016-S008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-669
• Device Lot Number: 3S210348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention