MAUDE Adverse Event Report: DUCKWORTH & KENT VITAN; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number	DK9000
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional 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.Unfolder handpiece is not an implantable device.Section d6b - if explanted, give date: not applicable.Unfolder handpiece is not an implantable device.D4 - expiration date: not available.Section e1 - telephone number: (b)(6).Section h3 - other (81): the unfolder handpiece 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.H4 - manufacturing date: not available.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the surgeon noticed a metal splint being injected into the eye, at the same time as the intraocular lens (iol) was being inserted.The metal splint was removed.No information was provided about any patient complications.Surgeon states that he has experienced this approximately 9 months ago, but did not take any action.The issue was first identified during implantation / application.The iol was fully inserted and no medications were reported.Through follow-up we learned that there was no resistance felt during lens preparation.It is unknown if the foreign material came from the lens or the inserter.No patient injury was reported.No further information was provided.Complaint (b)(4) was opened for the issue mentioned 9 months ago associated to this file.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 18-jul-2024 section h3 - device evaluated by manufacturer? yes device evaluation: the metal splint was not returned for evaluation; however, an image and dimensions were provided.The device showed signs of being well used and autoclaved with a couple of nicks in the center rod and some discoloration of the injector body.None of this gives cause for concern and the device remains fully operational.It has not been possible to ascertain where the metal fragment did come from, there were no visible signs that the fragment was once attached to the device.This would be evident by the appearance of an ¿uncolored¿ area on the device.Also, based on the physical size of the metal fragment, it could not have come from the inserter.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: VITAN
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): DUCKWORTH & KENT; 7 marquis business centre; royston road; baldock herts ; UK
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19081311
• Report Number: 3012236936-2024-00980
• Device Sequence Number: 12823986
• Product Code: MSS
• UDI-Device Identifier: 05050474651494
• UDI-Public: (01)05050474651494(17)991231(10)0089
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K191949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DK9000
• Device Catalogue Number: DK9000
• Device Lot Number: 0089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown