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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, 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 d4 - catalog #: a complete number is unknown, as product serial number was not provided.Section d4 - lot #: unknown/ not provided.Section d4 - expiration date: unknown, as product lot number was not provided.Section d4 - udi #: unknown, as product lot number was not provided.Section d6a - implant date: not applicable.The inserter is not an implantable device.Section d6b - explant date: not applicable.The inserter is not an implantable device.Section e1 - telephone number: (b)(6).Section h3 - the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.No lot number was provided for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Section h4 - device manufacture date: unknown, as product serial number was not provided.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.
Event or Problem Description
It was reported that following the implantation of a gcb00 model lens using the vitan injector, the surgeon observed a ¿small dot of metal¿ in the patient¿s eye after the procedure.The surgeon successfully retrieved the metal fragment from the eye, there was a delay in the procedure.It is unknown whether the metal originated from the inserter but could not have come from the gcb00 unit.The patient fully recovered, daily activities were not significantly affected.No further information was provided.
Additional Manufacturer Narrative
Additional information and corrected data: the suspect product received has lot number 0019.Therefore, the following fields have been updated accordingly as the lot number is no longer unknown: section d4-catalog number: the number provided on the initial report is the complete number.Section d4-lot number: 0019.Section d4-expiration date: no data available.Section d4-primary unique device identification (udi) number: (b)(4).Section h4-manufacturing date: no data available.All pertinent information available to johnson and 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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 23901003
• Report Number: 3012236936-2025-000325
• Device Sequence Number: 17425302
• Product Code: MSS
• UDI-Device Identifier: 05050474651494
• UDI-Public: (01)05050474651494(17)991231(10)0019
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 06/18/2026

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: 0019
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 06/12/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/28/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GCB00 MODEL IOL.
• Patient Sex: Unknown