MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA LENS; INTRAOCULAR LENS

Model Number	602
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer stated that the device will not be sent back, thus a proper device analysis could not be completed.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 of the lens.It was stated by the customer that the surgical technician loaded the iol with the wrong injector in addition to the use of an emerald injector.Our products are intended to be used with our injectors or other accessory support devices.It was stated by the customer that they used 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 caused or contributed to the reported issue are known to be caused by numerous factors including, but not limited to: loading strategy.Lens placement technique.Accessory device support.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.
Event or Problem Description
It was reported on (b)(6) 2023 that the lens was loaded incorrectly by the user during surgery on (b)(6) 2023, and explanted the dame day.There was patient contact, but the lens was not used.It was replaced by another lense during the same surgery.The doctor used the yamane technique.The customer stated that the device will not be sent back.

• Brand Name: CT LUCIA LENS
• Common Device Name: INTRAOCULAR LENS
• 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: 17551436
• Report Number: 3010126268-2023-00091
• Device Sequence Number: 6967588
• Product Code: HQL
• UDI-Device Identifier: 00843045101017
• UDI-Public: (01)00843045101017(17)260430
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

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: 04/30/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-680
• Device Lot Number: N/A
• 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: 07/18/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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