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

Model Number	602
Medical Device Problem Codes	Device Slipped (1584); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded, and is not being sent back.Therefore, a proper device analysis could not be completed.It was stated by the customer that no damage was noted during preparation for use.It was also stated that the customer, was using the yamane technique to implant the lenses.Thus, indicating a product quality issue did not contribute to the reported issues.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 factor may have cause or contributed to the damaged haptic is but is 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
On (b)(6) 2023, it was reported by doctor that the ct lucia 602 rotated after the iol was fixated using intrascleral haptic fixation, yamane technique.The iol looked well centered and in plane with the iris at end of surgery.On (b)(6) 2023, the iol had "sommersaulted" with forward 90-degree rotation so that instead of looking through the optic, both patient and examiner were looking at edge of optic.The patient adverse effects include, poor vision (hand motion), and iris chafing of the iol causing prolonged inflammation and inability to taper off steroid drops.The iol was explanted on (b)(6) 2023.The patient was left aphakic due to travel plans this summer.The doctor will go back in later and suture a lens to the sclera.

• 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: 17347344
• Report Number: 3010126268-2023-00087
• Device Sequence Number: 6068921
• Product Code: HQL
• UDI-Device Identifier: 00843045100904
• UDI-Public: (01)00843045100904(17)260630
• 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
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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: 06/30/2026
• Device Model Number: 602
• Device Catalogue Number: 003500-0050-669
• 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: 06/19/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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