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

Model Number	OPO71
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	09/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that endophthalmitis occurred on a patient 1 day postoperatively.Surgeon suspected opo71 (next generation phaco tubing dp-pack) and handpiece may have caused the issue.There were no details on the medication prescribed for the patients.Patients were recovering after a week.This event will capture patient 2 out of 3 patients and for the tubing product.A separate report is being submitted for the handpiece device.
Additional 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.It was also reported by the doctor that the direction for use (dfu) regarding the handpiece cleaning/sterilization were not followed in regards of the flushing (the flush was performed after removing the tip and sleeve).The account also admitted the re-use of the opo71 tubing during the three procedures when the tubing is labeled as single use only.The doctor understands the possibility that the re-use of the devices may have caused the event.No further information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: codes 4112, 4248 and 61 were added to section h6 based on completed product investigation.Base on follow up it was learned that "the handpiece and opo71 were reused for the three procedures; only the tip and sleeve were changed".Per z311152 rev b, dfu, fusion dual pump pack - opo71 multi, "do not resterilize and do not reuse"."the resterilization/reprocessing of amo single use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection and lack of product sterility".Based on the information obtained, there is no indication of product malfunction or product deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: it was reported that the date of event was september 10, 2022.Phaco tip and sleeve models were (b)(6) and (b)(6); the lot numbers were unknown.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: WHITESTAR SIGNATURE SYSTEM, FUSION PUMP
• Common Device Name: 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: 15602080
• Report Number: 3012236936-2022-02593
• Device Sequence Number: 19412005
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)250131(10)60345759
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60345759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 11/30/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/10/2022; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE MODEL 690880
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown