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

Model Number	602
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Codes	Keratitis (1944); Visual Impairment (2138)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, using the yamane technique, on october 23, 2023, the haptic of a ct lucia 602 broke while securing.The cornea started to swell due to difficult anatomy and manipulation.The procedure went 107 minutes beyond the planned time.The lens was explanted during the same procedure and discarded.The patient was left aphakic.There was no damage noted to the device during preparation for use.No issues post operation.
Additional Manufacturer Narrative
The customer stated that the device can not 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 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.There was no damage reported to have been noticed during the inspection prior to use and preparation, which suggests a product deficiency did not contribute to the reported difficulties.Based on the information provided, the risk assessment for the lucia product, and our experience, we have determined that the following factors may have caused or contributed to the reported issue, but are not limited to: · lens placement technique · loading strategy · accessory device support · poor handling during folding and inserting.

• Brand Name: CT LUCIA
• 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: 18378798
• Report Number: 3010126268-2023-00135
• Device Sequence Number: 12704523
• Product Code: HQL
• UDI-Device Identifier: 00843045100898
• UDI-Public: (01)00843045100898(17)280131
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/21/2023

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 Model Number: 602
• Device Catalogue Number: 003500-0050-668
• 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: Not provided
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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