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

Model Number DK9000

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It was reported that the intraocular lens (iol) was implanted with a scratch because of the inserter that was not working well.The iol was removed and replaced during the same surgery.No further detail was provided.

Manufacturer Narrative

Section a2, a4 and a5: per regulation eu (b)(4) (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 during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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.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: jan 2, 2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the customer provided a photograph for evaluation.Displayed was an implanted lens and damage could be observed to the optic body.The nature of the damage could not be determined from photographic evaluation.The complaint lens was received cut in half with one half missing.The lens was cleaned and presented with no additional issue.No smartload device was received for evaluation.Per the definition of "cosmetic issues" , the complaint issue could not be confirmed.However, the observed issue "lens damaged" is similar to the complaint issue "cosmetic issues" and could not be confirmed to be related to the manufacturing or design process.The complaint issue "cartridge damaged" could not confirmed during product evaluation as no product was received.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: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): DUCKWORTH & KENT; 7 marquis business centre; royston road; baldock herts PR SG7 6 XL; UK SG7 6XL
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18394688
• MDR Text Key: 331529331
• Report Number: 3012236936-2023-03193
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• 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: 0063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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