MAUDE Adverse Event Report: CARL ZEISS MEDITEC PRODUCTION LLC CT LUCIA 602; CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL

Model Number 003500-0050-676

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 11/08/2022

Event Type  Injury  

Event Description

It was reported that the doctor implanted the iol into the patient's eye and mentioned that everything looked good.Then he noticed that the iol tilted 45 degrees.Did not use a lens cartridge.He used a 7mm incision to insert the lens.The doctor removed the lens on (b)(6) 2022.The lens was replaced with a johnson & johnson lens.No patient injury was reported.

Manufacturer Narrative

The customer reported that they were using the ct lucia 602 for a yamane technique.For the most part it seemed to go well until they started closing all the incisions and that's when it was noticed the iol tilting.One of the other surgeons attempted to reposition the iol when one of the haptics dislocated and as he attempted to pull the other to try and anteriorize the iol, resulting in the iol dislocating.The surgery ended up taking an extra 2.5 hours because of the tilting of the lens.This included attempting to reposition after tilting, the optic falling to the back after separation from the haptics, replacing ports and removing the optic from the back of the eye, fixating a new lens to the sclera, and closing.In the process of removing the defective iol, it was necessary to scrape corneal epithelium due to deterioration of the view, leading to a complete corneal epithelial defect on postoperative day 1.No additional information provided.The device has is not being sent back.Thus, a proper device analysis could not be completed, nor the reported issues confirmed.It was mentioned by the customer that there was no damage noted during preparation for use indicating a product quality issue did not contribute to the reported issues.Additionally, 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.It was also stated they are using a c cartridge with monarch iii injector to implant lenses.Thus, the lenes are 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.

• Brand Name: CT LUCIA 602
• Type of Device: CT LUCIA 602, PRODUCT CODE: HQL, PRODUCT CODE: HQL
• 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: 16028858
• MDR Text Key: 305943030
• Report Number: 3010126268-2022-00057
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100016-S008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 003500-0050-676
• Device Catalogue Number: 003500-0050-676
• Device Lot Number: 3S211135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention