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

Model Number 003500-0050-675

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Eye Pain (4467)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

During the processing of this complaint, attempts were made to obtain complete event, patient, and device information.It was reported that a ct lucia 602 was implanted using the scleral fixation technique.The patient couldn't tolerate the pain caused by the scleral fixation technique; thus, the doctor decided to remove the lens and implant an anterior chamber lens.There were no adverse patient effects reported and no additional information provided.The customer is using scleral tunnel fixation to implant lenses.This technique induces a large amount of force while trying to position the haptics in the sclearl tunnel.Our lenses are intended to be implanted in the capsular bag; therefore, the technique used to implant the lenses are considered off label use.Additionally, it was stated that it was the patients inability to tolerate the pain from the sclearl fixation is the reason the lens was removed not due to a device malfunction.The device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lenses that would have contributed to the nature of this complaint.Additionally, lenses are 100 % inspected before they leave our manufacturing site.Therefore, we are confident that the lens was processed per standard operation procedures and inspections and met all of the criteria for release.Additionally, there was no damage noted to the lens during preparation for use which suggest a product deficiency did not contribute to the reported issue.We have reviewed the information provided and at this time there is no indication of a product quality issue with respect to the manufacturing, design, or labeling of the device.It appears that the reported issue is linked to off label use.However, the need to explant the lens is considered need for medical intervention in order to prevent and avoid permanent impairment or damage to a body structure.

Event Description

It was reported that a ct lucia 602 was implanted using the scleral fixation technique.The patient couldn't tolerate the pain caused by the scleral fixation technique; thus, the doctor decided to remove the lens and implant an anterior chamber lens.There were no adverse patient effects reported and no additional information provided.

• Brand Name: CT LUCIA 602
• Type of Device: 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: aileen sanchez ; 1040 s vintage ave. bld. a; ontario, CA 91761 ; 9099065165
• MDR Report Key: 12926799
• MDR Text Key: 285834735
• Report Number: 3010126268-2021-00006
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00843045100966
• UDI-Public: (01)00843045100966(17)260131
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 003500-0050-675
• Device Catalogue Number: 003500-0050-675
• Device Lot Number: 3S210092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2020
• 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