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

Model Number	602
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the iol rotated after being well centered and in good position.Lens was explanted and another lens implanted.
Additional Manufacturer Narrative
The device is not being sent back thus a proper device analysis could not be completed nor the reported issue 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.It was also stated that the customer is using a alcon monarch iol inserter to implant iols.Our lenses are intended to be implanted using r28 inserter and z28 cartridge.Thus, the lens was used off label.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 tilting is but is not limited to: loading strategy.Lens placement technique.Accessory device support.Poor handling during folding and inserting.Risk assessment has been reviewed within the technical file for hydrophobic lens.Risk assessment identifies decentration/ tilting of the iol inside the eye to potentially because by improper handling during surgery, imperfect surgical procedure.This is seen as a normal event that may result in additional surgery because of impaired vision.This is considered as a serious severity of damage that may result in injury or disability which requires surgical intervention.The likelihood of occurrence is estimated to be remote.The resulting risk is deemed acceptable.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.

• 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: 16358869
• Report Number: 3010126268-2023-00030
• Device Sequence Number: 6803868
• Product Code: HQL
• UDI-Device Identifier: 00843045101024
• UDI-Public: (01)00843045101024(17)260930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/10/2023

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: 09/30/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-681
• Device Lot Number: 3S211135
• 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: 01/20/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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