MAUDE Adverse Event Report: DUCKWORTH & KENT VITAN; INTRAOCULAR LENS GUIDE

Model Number DK9000

Device Problems Mechanical Problem (1384); Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

Information unknown/ not provided.Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: date unknown/ not provided.Expiration date: information not available at the time of this filing.If explanted; give date: not applicable as the material dk9000 is not an implantable device.If explanted; give date: not applicable as the material dk9000 is not an implantable device.Therefore, not explanted.Telephone number: (b)(6).Device manufacture date: information not available at the time of this filing.The intraocular lens (iol) has not returned for evaluation.Therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the plunger scratched over the iol (intraocular lens).The lens was almost implanted but the nurse saw that the plunger was not right, it was all over the optic.No additional information was received.

Manufacturer Narrative

Additional information: section h3: device evaluated by manufacturer? yes.Device evaluation: no physical products were returned for evaluation at the time of investigation.Images were provided.The three images depict the plunger rod of the vitan inserter having overridden the lens while inside the cartridge.No further details can be obtained through the images.Based on the information obtained, the reported issue is confirmed, however no product deficiency or malfunction can be confirmed.It is not known how many times prior to the reported event that the inserter was used and reprocessed.User/handling errors cannot be ruled out as the plunger rod may become bent as a result of handling.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: VITAN
• Type of Device: INTRAOCULAR LENS GUIDE
• 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: 15621769
• MDR Text Key: 306884895
• Report Number: 3012236936-2022-02617
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 05050474651494
• UDI-Public: (01)05050474651494(17)991231(10)0083
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 12/16/2022

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: 0083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1