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

Model Number	003500-0050-670
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after implantation of a ct lucia 602 it was noted the iol had opacitification.As of now the iol remains implanted.No additional information provided.
Additional Manufacturer Narrative
During the processing of this complaint, attempts were made to obtain complete event, patient, and device information.It was reported that after implantation of a ct lucia 602 it was noted the iol had opacification.The iol remains implanted.No additional information has been provided.The device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lenses that would have contributed to the nature of this complaint.Additionally, lenses are 100 % inspected before they leave our manufacturing site.Therefore, we are confident that the lens was processed per standard operation procedures and inspections and met all of the criteria for release.Opacification is linked to interactions with irrigating solutions, viscoelastic or aqueous humor in the eye, not iol related, and an event caused by the patient conditions which is known in literature.We have reviewed the information provided and at this time there is no indication of a product quality issue with respect to the manufacturing, design, or labeling of the device.It appears.

• 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
• MDR Report Key: 12573120
• Report Number: 3010126268-2021-00003
• Device Sequence Number: 11790289
• Product Code: HQL
• UDI-Device Identifier: 00843045100911
• UDI-Public: (01)00843045100911(17)220930
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P100016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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: 09/30/2022
• Device Model Number: 003500-0050-670
• Device Catalogue Number: 003500-0050-670
• Device Lot Number: 3S170935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention