MAUDE Adverse Event Report: TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number DFW100

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/23/2024

Event Type  Injury  

Event Description

It was reported that the preloaded intraocular lens (iol) was found to be luxated inside the patient's eye.Through follow-up, we learned that the iol has an optical defect.The patient is under observation and no injuries occurred.The left eye was affected.The iol was fully implanted and due to its dislocation it was removed from the patient's eye.Another iol was implanted in the same procedure.No further information was provided.

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Section e1 - telephone number: (b)(6).Section h3 - other (81): the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h6- health effect - clinical code 4581: no code available (device dislocation) attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 07-mar-2024 section h3 - device evaluated by manufacturer? yes device evaluation: the product was returned to the manufacturing site for evaluation.The lens was visually inspected under magnification revealing that the lens was cut in half.No issues that could cause or contribute to the complaint issues were observed.The compliant simplicity was visually inspected under magnification and no issues were observed.The customer provided photographs for evaluation.The first photograph displays the suspect simplicity on the plastic tray holder.No issues could be identified.The second photograph shows the suspect lens inside a glass vial; due to the quality of the photograph no issues could be identified.The complaint issue "instability of device after implantation" and "lens damaged" were not identified during product and photo evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• MDR Report Key: 18717976
• MDR Text Key: 335529368
• Report Number: 3012236936-2024-00285
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DFW100
• Device Catalogue Number: DFW100I225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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