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

Model Number	003500-0050-681
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor was using the yamane scleral fixation technique to implant a ct lucia 602, it was noted that the haptic was broke.Thus, the lens was removed, and a second lens was attempted to be implanted.However, the iol continued to tilt upward preventing good centration and proper placement.Thus, this lens was removed, and another lens was implanted to successfully complete the procedure.No adverse patient effects 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.This report will also capture serial number (b)(4).Udi # (b)(4).It was reported that the doctor was using the yamane scleral fixation technique to implant a ct lucia 602, it was noted that the haptic was broke.Thus, the lens was removed, and a second lens was attempted to be implanted.However, the iol continued to tilt upward preventing good centration and proper placement.Thus, this lens was removed, and another lens was implanted to successfully complete the procedure.No adverse patient effects reported no additional information provided.The devices are not 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.Additionally, it was stated that the customer is using the yamane technique to implant lenses.This technique induces a larger amount of force while trying to position the haptics in the scleral tunnel.Our lenses are intended to be implanted in the capsular bag; therefore, the lenses are being used off-label.It was also stated that they are using b cartridge and alcon inserter to inject the lenses our lenses our intended to be implanted using a z 28 cartridge and r28 inserted.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 iol damaged haptic is but is not limited to: lens placement technique 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.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 and since the patient was left aphakic we are reporting this incident.

• 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: charlie ortiz ; 1040 s vintage ave. bld. a; ontario, CA 91761 ; 9099065165
• MDR Report Key: 15611322
• Report Number: 3010126268-2022-00021
• Device Sequence Number: 2749067
• Product Code: HQL
• UDI-Device Identifier: 00843045101024
• UDI-Public: (01)00843045101024(17)260831
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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: 04/30/2026
• Device Model Number: 003500-0050-681
• Device Catalogue Number: 003500-0050-681
• Device Lot Number: 3S211019
• 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: 09/22/2022
• Initial Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2021
• 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