MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. UNK_I/A HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number UNK - I/A HANDPIECE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Infections (4466)

Event Type  Injury  

Event Description

It was reported that there was a case of infection in which the customer has not been able to isolate the source and believe it could be their solo irrigation/aspiration (i/a) handpiece.Patient was provided medical treatment for the infection and is expected to have a full recovery.No additional information has been provided.

Manufacturer Narrative

A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: through follow up it was reported to jnj that the issue of the infections had been resolved by the customer (internally) and that the cause was identified to be a new employee that was not following proper aseptic protocols.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Correction: in follow up #1 it was reported that the issue of the infections had been resolved by the customer (internally) and that the cause was identified to be a new employee that was not following proper aseptic protocols.It was failed to mention that the j&j device is no longer a suspect product as it did not cause or contribute to the reported event based on the information that was received from the customer.Therefore, the reportability of this case was downgraded, and no additional information will be provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK_I/A HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618
• MDR Report Key: 19001469
• MDR Text Key: 338885605
• Report Number: 3012236936-2024-00986
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK - I/A HANDPIECE
• Device Catalogue Number: UNK - I/A HANDPIECE
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 03/27/2024; 04/18/2024
• Supplement Dates FDA Received: 04/18/2024; 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention