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

Model Number DK9000

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

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 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.

• Brand Name: VITAN
• Type of Device: 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
• MDR Text Key: 340598946
• Report Number: 3012236936-2024-00980
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 05050474651494
• UDI-Public: (01)05050474651494(17)991231(10)0089
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K191949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

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
• Device Operator: Health Professional
• Device Model Number: DK9000
• Device Catalogue Number: DK9000
• Device Lot Number: 0089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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