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

Model Number	003500-0050-675
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a ct lucia 602 lens was inserted into a patient's eye it was noted that the haptic was broken.The iol was removed from the eye successfully without patient injury.Spare lens was used to complete the procedure.No adverse patient effects or clinically significant delay in procedure reported.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 a ct lucia 602 lens was inserted into a patient's eye it was noted that the haptic was broken.The iol was removed from the eye successfully without patient injury.Spare lens was used to complete the procedure.No adverse patient effects or clinically significant delay in procedure reported.No additional information 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.Additionally, there was no damage noted to the lens during preparation for use which suggest a product deficiency did not contribute to the reported issue.Damaged haptics are known to be caused by numerous factors including, but not limited to: loading strategy.Lens placement technique.Poor handling during folding and inserting.Patient pathology.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 that the reported issue is linked to user error.However, the need to explant the lens is considered need for medical intervention in order to prevent and avoid permanent impairment or damage to a body structure.

• 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: 12606192
• Report Number: 3010126268-2021-00004
• Device Sequence Number: 14481367
• Product Code: HQL
• UDI-Device Identifier: 00843045100966
• UDI-Public: (01)00843045100966(17)260131
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 10/08/2021

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: 01/31/2026
• Device Model Number: 003500-0050-675
• Device Catalogue Number: 003500-0050-675
• Device Lot Number: 3S210092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/11/2021
• 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