MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. VITAN; UNFOLDER HANDPIECE

Model Number DK9000

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth, weight and ethnicity: information unknown/ not provided per country's personal data privacy legislation/policy.Date of event: unknown as the exact date could not be provided.The best estimate date is (b)(6) 2021.Device product code: mss expiration date: information not available at the time of this filing.If explanted; give date: not applicable as the handpiece is not an implantable device.If explanted; give date: not applicable as the handpiece is not an implantable device.Therefore, not explanted.First/given name: unknown/not provided.Email address :unknown/not provided.Telephone number:(b)(6).Device manufacture date: information not available at the time of this filing.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, labeling, 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.An attempt was made to obtain the missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the cartridge tip of the preloaded intraocular lens (iol) device, model gcb00, was frayed by the injector (vitan handpiece, model dk9000, lot 0066).Account indicated that a sickle-shaped part is hanging from the tip.The lens was successfully implanted.There was no harm to the patient and no medical intervention was required.No additional information was provided.This is report 1 of 2.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes section d9 - date returned to manufacturer: 3rd february 2022 section h3: device returned to manufacturer? yes device evaluation: two dk9000 smartload vitan handpiece inserters were received for evaluation, however it was unknown which handpiece was used for which of the two reported events.A visual inspection of both inserters reveals the tips of both plunger rods had become bent.How and when this damage was introduced cannot be determined.It was determined that the damage to the cartridges is most likely to due to the bent pushrod of both handpieces.The material of the pushrod is titanium, which would need to be subjected to an impact or force that would result in damage to the pushrod tip.As such, the pushrod would have had to be subjected to the damage (bending of the pushrod tip) by some other action outside of normal lens delivery.There is no further information provided to indicate when this damage may have occurred.It was noted that per direction for use: "prior to each use, visually inspect the rod tip of the handpiece to ensure that there are no material deposits or damage." moreover, under warnings: "do not use the inserter if the rod tip appears nicked or damaged in any way because the rod may override and/or damage the iol resulting in the need to exchange the iol" as there is no other information provided regarding the use of the handpiece that would suggest improper use of the device, it is most likely that the pushrod tip was damaged prior to use of the device for lens delivery.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
• Type of Device: UNFOLDER HANDPIECE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13064038
• MDR Text Key: 288491093
• Report Number: 3012236936-2021-00320
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 05050474651494
• UDI-Public: (01)05050474651494(17)991231(10)0066
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/09/2022

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: 0066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PRELOADED CARTRIDGE, MODEL GCB00