MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE SYSTEM, FUSION PUMP; UNIT, PHACOFRAGMENTATION

Model Number OPO71

Device Problem Material Twisted/Bent (2981)

Patient Problems Corneal Clouding/Hazing (1878); Blurred Vision (2137); Eye Burn (2523)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that the customer had a complication resulting in a burnt cornea.The tube was sprained which meant that there was no cooling.As per the customer, the defect tubing was noticed after the complications occurred to the patient's eye.One day post operatively, the patient was taken urgently to (b)(6), due to a very hazy cornea.Result unknown when reported.They were then taken to (b)(6) hospital.Through follow-up we learned that additional surgical interventions were required one day and 2 days post the initial operation.The patient did not require an overnight hospital stay.Additional medical intervention was also required.We were told the patient doesn´t feel well.Her vision is very blurry and she is worried about this.The customer was supplied with the product from mölnlycke packs and not directly from jj.There is no material available for investigation.No further information was provided.

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section e1 - telephone number: (b)(6).Pi open: there was no material available for evaluation, as it had been discarded.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.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.

• Brand Name: WHITESTAR SIGNATURE SYSTEM, FUSION PUMP
• 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 ; 7142478552
• MDR Report Key: 19028382
• MDR Text Key: 339205947
• Report Number: 3012236936-2024-00735
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 35050474534446
• UDI-Public: (01)35050474534446(17)251212(10)60419995
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/02/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60419995
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female