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

Model Number	OPO71
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uveitis (2122)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device evaluation: product is not available for investigation, therefore no testing could be performed.The reported event cannot be confirmed.For this lot, all devices meet material, assembly, and performance specifications at the time of product release.No related deviation, ncmr, nc or capa was initiated during the manufacturing process of the reported lot#.All devices meet material, assembly, and performance specifications at the time of product release.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.Additional information: customer reported that they did their retrospective investigation and they suspect the ophthalmic viscosurgical device (ovd) which is not a johnson & johnson surgical vision (jjsv) product and our opo71 tubing.Although they also reported that they agree the tubing was sterile and not in direct contact with the eye.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Doctor reported that patient had surgery on (b)(6) 2021 and presented six days post treatment with uveitis.This is fifth out of eight reports/patients.It was also reported by the account that some of the patients required hospitalization however no details were provided of which patients required it and which ones did not.No patient details were provided.
Additional Manufacturer Narrative
Additional information: through follow up it was learnt that the topical, systemic and intraocular treatment was required.The medication prescribed by doctor was part of the standard of care.The lens remains implanted and patient is being monitored.There has been no pattern observed by the doctor in the reported cases and the customer reports that there is no assignable root cause of the uveitis.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: 13503676
• Report Number: 3012236936-2022-00368
• Device Sequence Number: 11760203
• Product Code: HQC
• UDI-Device Identifier: 05050474534445
• UDI-Public: (01)05050474534445(17)231127(10)60270118
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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: 11/27/2023
• Device Model Number: OPO71
• Device Catalogue Number: OPO71
• Device Lot Number: 60270118
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown