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	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned therefore a proper root cause analysis could not be completed nor the reported issue confirmed.The customer stated that they are using the yamane technique to implant the 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.Thus, the lens was being 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 factors may have cause or contributed to the damage haptic is but is not limited to: loading strategy, lens placement technique, accessory device support and poor handling during folding and inserting.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.Risk assessment has been reviewed within the technical file for 3pc hydrophobic lens.Risk assessment identifies damage of iol optic and/or haptic to potentially be caused by use of inappropriate surgical instrument or improper handling or improper implantation technique.This is seen as a reasonably foreseeable misuse that may result in additional surgery because of impaired vision; and potential iol explantation.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 occasional.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.
Event or Problem Description
It was reported that the haptic broke.Lens was removed and another lens was implanted.
Additional Manufacturer Narrative
Correction: follow up # 2 made because evaluation summary was not attached during follow up #1.
Additional Manufacturer Narrative
Field d9: updated to "yes" field g3: updated "date received by manufacturer" field g6: updated to "follow-up # 1" and "30-day" field h2: selected "correction, additional information, and device evaluation" field h3: updated to "yes".Checked "evaluation summary attached" box field h6: added type of investigation to "10".Added code "18" to investigation conclusions codes.Field h10: added description of changes.

• 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
• MDR Report Key: 17210908
• Report Number: 3010126268-2023-00085
• Device Sequence Number: 17725614
• Product Code: HQL
• UDI-Device Identifier: 00843045100904
• UDI-Public: (01)00843045100904(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P10016-S008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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: 07/31/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-669
• Device Lot Number: 3S210960
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 06/28/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/13/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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