MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA 621P

Model Number	621P
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device cannot be returned therefore a proper root cause analysis could not be completed nor the reported issue confirmed.Without a proper device analysis, a definitive root cause cannot be determined at this time.It was stated by the customer that there was no damage noted to the device during preparation for use and there were no adverse effects on the patient.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 damaged haptic issues are but not limited to: dwell time after preparation: the ifu recommends that after the lens is advanced into the conical section the lens must be injected immediately.Dwell scenarios where the lens sits in this position for a prolong time prior to injection may lead to stuck iol issue.Viscoelastic materials may lose their lubricity if allowed to stand too long.Misplacement of the lens.This which may occur during ovd application, the cannula may catch the edge of the lens or haptic; thus, removing the lens off the "track" which is inside the cartridge.This may also cause the lens to fold improperly.The lens should fold in a "u" shape and if it does not this will cause the lens to not eject correctly and could even cause the lens to get damaged.Inadequate application of ovd.The ifu asks for generous amount of ovd to be applied, which covers the lens and the blue cushion.If ovd is not placed on the blue cushion advancement of the plunger may be inhibited by high frictional force and appear to become stuck.Risk assessment has been reviewed within the technical file for hydrophobic lens.Risk assessment identifies failed injection or damaged haptic to possibly be caused by the lens improperly loaded such that the optic is bent, or haptics are under compression.This is seen as a reasonably foreseeable misuse, that may result in extended surgery because of damage to the lens/injector and replacement is required.This is seen as a minor severity of damage that may cause temporary injury or disability which requires no additional 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
After insertion/lens unfolding of a ct lucia 621, an amputated leading haptic was observed by the doctor.The lens was explanted, and a secondary lens implanted in the same surgery.

• Brand Name: CT LUCIA 621P
• Common Device Name: CT LUCIA 621P
• 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: 17558570
• Report Number: 3010126268-2023-00093
• Device Sequence Number: 17404595
• Product Code: HQL
• UDI-Device Identifier: 00843045102304
• UDI-Public: (01)00843045102304(11)230330(17)240831
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/16/2023

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: 08/31/2024
• Device Model Number: 621P
• Device Catalogue Number: 003500-0056-484
• Device Lot Number: 3S230376
• 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: 08/01/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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